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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. BI-POLAR 28 CUP 41MM FEMORAL HEAD BIPOLAR COMPONENT

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BIOMET UK LTD. BI-POLAR 28 CUP 41MM FEMORAL HEAD BIPOLAR COMPONENT Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 02/01/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Report source, foreign - event occurred in (b)(6). The product has been returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the plastic component (insert) of the product was missing from the package. No patient involvement. No delay of the procedure.

 
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Brand NameBI-POLAR 28 CUP 41MM
Type of DeviceFEMORAL HEAD BIPOLAR COMPONENT
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key9796618
Report Number3002806535-2020-00118
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 03/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number165206
Device LOT Number6596871
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/29/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/14/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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