Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 when the team opened the implant, the stem was wedged into the top of the packaging which was folded over.Upon further inspection they questioned the sterile integrity as the packaging looked scuffed potentially perforated.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.
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Event Description
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No further information at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d4; g3; h2; h3; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the reported event against the complaint history suggests that the cushion became folded and the pouch was scuffed during transit.There is no indication that sterility was breached as there is no report of a damage blister.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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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Search Alerts/Recalls
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