Catalog Number 180552 |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
Event Type
Injury
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Event Description
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It was reported a patient underwent a right shoulder revision due to malposition of the device.All components except the humeral stem were removed and replaced with an anatomic shoulder system.It was noted the patient will undergo another revision; however, the date and procedure are yet to be determined.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports.0001825034-2023-01188.Item#110027734; lot#652460.0001825034-2023-01189.Item#180551; lot#unk.0001825034-2023-01190.Item#180551; lot#unk.0001825034-2023-01191.Item#180552; lot#unk.0001825034-2023-01193.Item#115397; lot#unk.Other associated products: item#110031424; lot#65425320.Item#110031401; lot#64490866.Item#115310; lot#j7280809.Item#110031378; lot#652480.Item#113650; lot#65213817.Item#405889; lot#584520.Item#110028045; lot#016680.Item#110019066; lot#652490.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the glenoid component appears to be inferomedially displaced from the glenoid fossa and the central screw appears extraosseous.However, the glenoid and humeral implants are maintained in alignment.There is no fracture identified.Correlation with earlier images would be of value in determining interval change in implant position.Bone quality is osteopenic.The glenoid implant appears loose and displaced but correlation with earlier images would be of value.A definitive root cause cannot be determined.The reported event is confirmed by mmi review.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 is available at the time of this report.
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Search Alerts/Recalls
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