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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN AMC CERAMIC HEAD UNKNOWN HIP ARTHROPLASTY

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BIOMET UK LTD. UNKNOWN AMC CERAMIC HEAD UNKNOWN HIP ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Foreign report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, because it remains implanted. Concomitant medical products: medical product: unknown bimetric stem, catalog #: unknown, lot #: unknown. Medical product: unknown m2a-38, catalog #: unknown, lot #: unknown. Postal code: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

-patient 8 in m2a38 mom vs com study. -description: raised metal ions. Abnormal mri scan. Armd suggested. -treatment: none at present. Added to waiting list for revision surgery. -related to procedure: yes. -related to device:yes. -outcome: pending. It was reported that a patient participating in a clinical study for mom vs com showed abnormal mir scan with raised metal ions.

 
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Brand NameUNKNOWN AMC CERAMIC HEAD
Type of DeviceUNKNOWN HIP ARTHROPLASTY
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 Key10108514
Report Number3002806535-2020-00271
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberN/A
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/02/2020 Patient Sequence Number: 1
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