Catalog Number 154600 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Information (3190)
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Event Date 03/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 during an initial partial knee arthroplasty, the inner packaging of the implant had a liquid residue.Another device was used to complete the procedure.Due to the event, there was a delay in procedure of approximately one to two hours.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).The returned product was evaluated for the reported liquid residue inside the sterile packaging (pouch).The pouch was opened and separated in order that the inside could be checked for liquid residue.There was no evidence of any form of liquid or moisture on the inside of the pouch.The implant was also checked for staining from liquid/moisture from the inside of the pouch.There was no evidence of staining on the implant.The scuffing around the implant and the inner seal starting to separate could have the visual effect of moisture within the pouch due to its opaque effect.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints data base has revealed 2 similar complaints for the reported issue.All 3 complaints are reported from (b)(6).(b)(4).The product was likely conforming when it left zimmer biomet control.
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Search Alerts/Recalls
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