ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE TIBIAL COMPONENT CEMENTED SIZE G RIGHT MEDIAL; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Date 10/09/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a right knee arthroplasty to address tibial loosening and pain that increased with weight-bearing approximately four (4) 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).D10 - concomitant devices - persona partial knee articular surface right medial size g 8mm catalog #: 42528200708 lot #: 64157607, persona partial knee femoral component cemented size 3 right medial catalog #: 42558000302 lot #: 63982592, biomet bone cement r 1x40 us catalog #: 110035368 lot #: 824fac2202.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: 0001825034-2023-02598.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Radiographic review identified possible polyethylene wear, however, no tibial loosening was noted.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-02597, 0001825034-2023-02598, 0001825034-2024-00651.
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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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