Model Number N/A |
Device Problem
Scratched Material (3020)
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Patient Problems
Hematoma (1884); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Foreign Body In Patient (2687); Swelling/ Edema (4577)
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Event Date 04/25/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent an initial knee surgery.Subsequently, approximately 5 years later, the surgeon had taken the patient to do a wound debridement due to swelling and pain of right knee post replacement.While the wound was open, the surgeon observed abnormalities of the articular surface and he removed the implant and inserted a new articular surface.The poly appeared to have fine scratches.Infection was also noted to be present.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).D10: unknown - unknown tibial component - unknown.Unknown - unknown femoral component - unknown.G2 : foreign country : south africa.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 available at the 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.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of wear with nicks, gouges, and pits.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: cement debris was lodged between the iliotibial band in initial surgery, pain and swelling, hemarthrosis, limited rom, abnormalities of the articular surface, ossific densities are noted laterally within the joint space, in the region of the iliotibial band, mild osteopenia, no signs of loosening, wear, radiolucency, or malalignment.A definitive root cause cannot be determined.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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Event Description
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No further event information available at the 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.The following sections were updated: b4; b5; b6; b7; d2; d10; e1; g1; g3; g6; h1; h2; h6.D10: unknown - unknown cement - unknown product has been received by zimmer biomet and 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 further reported that the patient underwent an initial right total knee arthroplasty.Approximately 6 weeks post-op, the patient presented to the office with pain and swelling.A knee aspiration was done with negative results and improvement on range of motion.Approximately 6 weeks later, the patient had a debridement of hemarthrosis, soft tissue, and cement debris with negative cultures.Subsequently, 3 months later, the patient underwent a second incision and drainage procedure due to no improvement in symptoms.During the procedure, the surgeon noted abnormalities to the articular surface.The articular surface was exchanged without complications.Attempts have been made and all available information has been provided.
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Search Alerts/Recalls
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