Catalog Number PT-113950 |
Device Problem
Fracture (1260)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 11/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -03008.D10: sm hybrid glenoid base 4mm cat: 113952 lot: 346830.G2: foreign: australia.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
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Event Description
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It was reported patient was revised due to rotator cuff failure and implant fracture approximately eight months post operation.The glenoid post and poly were exchanged.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: versa-dial 42x18x46 hum head; cat: 113032; lot: 293080.Compr nano hmrl pps 30mm; cat: 115730; lot: 271400.Versa-dial/comp ti std taper; cat: 118001; lot: 386740.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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It was reported patient underwent a revision procedure approximately 21 months post implantation due to rotator cuff failure and glenoid post implant fracture.The humeral and glenoid components were removed and exchanged without complication.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified signs of use with some debris around the threads of the glenoid base as well as some scratches, gouges, and debris embedded into the working surface of the glenoid base.The threaded posts also have damage near the top of the threads.The regenerex post is fractured and not all of the post was returned.Fracture analysis could not be performed as the fracture is too smeared.Device history record was reviewed and no discrepancies were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the right shoulder demonstrate a shoulder arthroplasty with radiolucent glenoid component and what appears to be a fractured central peg.Humeral component is intact with radiolucency along the baseplate.Superior subluxation of the humeral head is noted on the second image.The reported event is confirmed.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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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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