Model Number N/A |
Device Problems
Fracture (1260); Mechanical Problem (1384)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant has returned the products to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.
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Event Description
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It was reported that the provisional shim became fractured.Attempts have been made, however, no additional information is available at this time.
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Manufacturer Narrative
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Visual inspection of the returned item found it exhibited signs of repeated use and had fractured on the medial side of the post feature.Not all pieces were returned.Evaluation of the returned device identified the fracture was consistent with the tibial articular surface provisional (tasp) fractures analyzed and identified that the common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not 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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