Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign ¿ canada.The 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 mdr will be submitted.
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Event Description
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It was reported that during surgery, the liner could not be placed in the cup.A new liner was used to complete the procedure.There was no known impact or consequences to the patient.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).Visual examination of the returned product/provided pictures identified gouges and indentations to the rim, inner spherical surface, and elevated anti rotation scallops.Cut outs on the outer spherical surface show indentations and deformation from attempted implanting.No other damage was noted.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.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 information is available at the time of this report.
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Search Alerts/Recalls
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