title: Adverse events associated with biodegradable lactide-containing suture anchors.
abstract: OBJECTIVE
  To evaluate the occurrence of adverse events and inflammatory reactions related to the use of biodegradable anchors.
  
  
  METHODS
  A retrospective review of a consecutive series of arthroscopic shoulder procedures using biodegradable suture anchors performed by a single surgeon was undertaken. The database was purged of patient identifiers. The blinded data were analyzed for procedure type, anchor type and composition, associated procedures, and general demographic data. Anchor composition and number were recorded. A shoulder procedure after the index operation was considered an adverse event. The nature of these procedures was evaluated using medical records, operative images, and video, looking specifically for inflammatory reactions. Any anchor-related issues were documented.
  
  
  RESULTS
  Three hundred sixty cases met the inclusion criteria. The procedure was a tendon repair (rotator cuff or biceps) in 265 cases and a labral repair (instability or SLAP) in 97, 2 of which were combined instability and tendon repairs. Nine different biodegradable anchors were identified, possessing 4 different polymer combinations. Adverse events (reoperations) were identified in 18 of 360 patients (5%): 13 tendon repairs and 5 labral/instability repairs. Only 2 were anchor related. In 1 tendon repair case, the anchor broke and an anchor fragment required removal. In 1 labral repair case, the anchor eyelet (a suture) loosened from the anchor body and eroded the humeral head. No cases of inflammatory synovitis were observed. No statistical difference in adverse event rates existed between tendon and labral repairs (P > .05).
  
  
  CONCLUSIONS
  Anchor-specific adverse events occurred in 2 of 360 procedures (0.5%). One was anchor design related (the prominent head containing the suture eyelet broke off) in a poly-L-lactic acid (PLLA) anchor. One was anchor material related and occurred when the poly-levo (70%)/dextro (30%)-lactide anchor body reabsorbed, loosening the encased eyelet suture and allowing this suture to migrate into the joint. No inflammatory reactions were documented in the slowly degrading pure PLLA or more rapidly degrading biocomposite PLLA/β-tricalcium phosphate-based anchors.
  
  
  METHODS
  Level IV, retrospective review, therapeutic study.
authors.affiliation: Sports Trauma, Mexico City, Mexico.
authors.forename: Andres F
authors.initials: AF
authors.lastname: Cobaleda Aristizabal
authors.affiliation: Plano Orthopedic Sports Medicine and Spine Center, Plano, Texas, U.S.A.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Sanders
authors.affiliation: Plano Orthopedic Sports Medicine and Spine Center, Plano, Texas, U.S.A.
authors.forename: F Alan
authors.initials: FA
authors.lastname: Barber
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001182:Arthroscopy / Q000295:instrumentation* / Q000379:methods; D004146:Dioxanes / Q000009:adverse effects*; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D006811:Humerus / Q000293:injuries*; D008297:Male; D008875:Middle Aged; D019637:Orthopedic Procedures / Q000295:instrumentation; D012189:Retrospective Studies; D017006:Rotator Cuff / Q000601:surgery*; D012782:Shoulder / Q000601:surgery*; D053441:Suture Anchors / Q000009:adverse effects*
chemical_list: D004146:Dioxanes; C091880:dilactide