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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. UNKNOWN MOM HEAD Back to Search Results
Model Number N/A
Device Problem Metal Shedding Debris
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products- unknown mom shell, therapy date - unknown. Report source, foreign - event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-00836.

 
Event Description

It has been reported by the patient's legal representative that the patient underwent a right hip replacement procedure. Subsequently,the patient alleges undefined damages caused by unknown mom biomet implant. Elevated metal ion levels were reported. This report is based on allegations set forth in patients notice and the allegations there in are unverified.

 
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Brand NameUNKNOWN MOM 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 Key7532665
Report Number3002806535-2018-00840
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 04/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/03/2019
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

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