ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL KNEE HIGH FLEX PRECOAT CEMENTED FEMORAL COMPONENT; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling/ Edema (4577)
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Event Date 03/11/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a left knee arthroplasty revision to address recurrent pain, swelling and suspected metal allergies approximately eight (8) years post-operatively.Attempts have been made, however, no additional information is available.
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Manufacturer Narrative
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(b)(4).Concomitant medical devices - zimmer unicompartmental knee precoat tibial component size 2 catalog #: 00584200201 lot #: 64689784, zimmer unicompartmental knee articular surface size 2 8mm catalog #: 00584202208 lot #: 64683524.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2023-00865 and 0001822565-2023-00866.Investigation incomplete.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (g04) - femur.Medical records received were reviewed and confirmed significant inflammation, increase in activity present in the left knee joint, grade 4 chondral wear, and a synovectomy during the revision.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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