ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problems
Loss of Range of Motion (2032); Swelling (2091); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: persona stemmed 5-degree tibia, catalog #: 42532007102, lot #: 63695869; persona cr femur, catalog #: 42502606402, lot #: 63654152; persona all poly patella, catalog #: 42540000032, lot #: 63716230; persona cr articular surface, catalog #: 42521000510, lot #: 63545961.Customer has indicated product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00123; 0002648920-2019-00290; 3007963827-2019-00125.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.Device remains implanted in patient.
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Event Description
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It was reported patient underwent a right total knee arthroplasty.Subsequently, post-manipulation procedure, the patient is continuing to experience noise, loss of range of motion, leg length discrepancy, swelling, unable to straighten leg to the full degree, limited mobility, numbness, ambulates with a cane, and alleges "knee giving out." no revision procedure has been reported to date.
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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.Reported event was confirmed by review of medical records.Review of medical records identified that the patient under went manipulation under anesthesia due to pain, swelling, and limited rom, and the signs/symptoms continue to be an issue.Device history record (dhr) was reviewed and no discrepancies were found.Per the package insert, pain, swelling, leg length discrepancy, and poor range of motion are known potential adverse effects of the procedure.However, a definitive root cause could not 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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