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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN RECAP HEAD

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BIOMET UK LTD. UNKNOWN RECAP HEAD Back to Search Results
Model Number N/A
Device Problem Metal Shedding Debris
Event Date 11/07/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products - product - unknown recap shell, therapy date - (b)(6) 2016. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported by the patient's legal representative that the patient underwent an initial right hip arthroplasty. Subsequently, a revision procedure was performed due to pain and elevated metal ion levels.

 
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Brand NameUNKNOWN RECAP HEAD
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 Key7503718
Report Number3002806535-2018-00791
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 10/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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

Patient TREATMENT DATA
Date Received: 05/10/2018 Patient Sequence Number: 1
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