Catalog Number 00434906600 |
Device Problem
Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 09/15/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a shoulder procedure on an unknown date.Subsequently, the patient was revised approximately one (1) month ago due to instability of the implants.Additional attempts to gain information have been made with no additional information received at this time.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02949.Concomitant medical products: item#: unknown, unknown glenoid; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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 reported that the patient underwent an initial shoulder arthroplasty nine (9) years and nine (9) months ago.Subsequently the patient was revised approximately two (2) months ago due to instability of the implants.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02949-1.D10: item#: 00434904011, 40mm a glenosphere; lot#: 62222979.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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(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02949-2 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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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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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