Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pain (1994); Synovitis (2094); Ambulation Difficulties (2544); Insufficient Information (4580)
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Event Date 12/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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Cmp-(b)(4) medical product: unknown femoral component: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.Multiple mdr reports have been filed for this complaint.Please see associated reports: 0001822565-2022-03347; 0001822565-2022-03349.Customer has indicated that the product is unavailable for return to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported via a clinical study that a patient underwent an initial total knee arthroplasty.Subsequently, eight(8) years post-implantation, the patient underwent a debridement with a synovial biopsy for unknown reasons.Due diligence is in process for this event; to date no further information has been reported.
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Event Description
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It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, eight(8) years post-implantation, the patient underwent a debridement with a synovial biopsy for pain, difficulty ambulating, limited daily activities and decreased range of motion.During the debridement noted minor wear to the articular surface with erosion of the tip of the bearing and synovitis.The debridement was completed without complication.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: medical product: unknown nexgen femoral component size g: catalog#ni, lot#ni; unknown nexgen articular surface 10mm: catalog#ni, lot#ni; unknown patella component size 41: catalog#ni, lot#ni; unknown bone cement: catalog#ni, lot#ni.An additional mdr report has been filed for this event.Please see additional associated report: 0001822565-2022-03537.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further event information at time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records shows that the patient experienced pain, range of motion issue after 8 years of the initial surgery.X-rays shows the implant was stable and no fracture.During the debridement procedure, minor pitting and erosion on the articular surface.Also, diffused the synovitis.No complication was noted.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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