(b)(4).Concomitant medical products: item # 163132 item name 28mm mod hd ceramic std nk lot #163132.Item # 103531 item name ti low profile screw 6.5x20mm lot #083740.Item # 103530 item name ti low profile screw 6.5x15mm lot #442770.The device will not be returned for analysis as product location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04445.
|
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent a right tha on an unknown date approximately 13 years prior.(b)(6)2009 office visit pt complaint of some mild buttock and thigh pain.X-ray findings show evidence of asymmetric poly wear without osteolysis.Operative report demonstrated excellent in-growth, removed head without difficulty, morse taper appeared to be in excellent condition.Moderate amount of bursitis about trochanteric claw.Cables cut and removed claw without difficulty.Large posterior osteolytic cyst approximately 3 to 4 cm in length and 2 cm in width, removed.Packed with autologous remings and allogenic crushed cancellous bone graft.Locking mechanism damaged by wear which was worn through a bit of poly onto the metallic shell.Cup was a bit too vertical, possibly resulting in the superior wear pattern.Decided based on vertical position of cup, difficulty with locking mechanism, and unavailability of cup presently to revise entire acetabular component.-a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|