Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)
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Event Date 08/11/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: articular surface catalog # 00584202209, lot # 62849181, femoral component catalog # 00584201302, lot# 62543939.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-00945, 1822565-2016-00090.Product location is unknown.
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Event Description
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It was reported that the patient had initial right knee arthroplasty.The patient was experiencing pain, swelling, limited range of motion, balance issues with restrictions on activities post implantation.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Root cause was unable to 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.
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Search Alerts/Recalls
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