Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/21/2022 |
Event Type
Injury
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Event Description
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It was reported that the stem broken.Patient outcome - revision due to implant fracture.
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Manufacturer Narrative
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The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional and/or corrected information.D10 concomitant medical products: revitan, proximal stem.Product: 0100401065.Lot: 2522918.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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No change to previously reported event.
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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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(b)(4).The follow-up report is being submitted to relay/additional and/or correct information.The following sections were updated: visual examination of the returned product showed that the biolox delta head shows diffuse metallic smearing on the articulation surface as well as on the bottom bevel.The connection pin of the distal revitan stem is fractured in the non-blasted area.The proximal part of the connection pin is still assembled to the proximal part of the revitan stem.The proximal and distal fracture surfaces show a fatigue fracture.The fracture origin is located on the lateral side.On the proximal part of the revitan stem, spots from the use of an electrocautery tool can be found on the neck.Slight polishing can be seen on the medial side of the anchoring surface, most likely deriving from movement against bone.There are no signs of bone ongrowth on the anchoring surface of the proximal stem part.On the distal part of the revitan stem bone attachments are visible.Various scratches and nicks can be seen on the anchoring surface of the stem.These damages can be attributed to the revision surgery.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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