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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH METASUL HEAD HIP IMPL WIN

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ZIMMER GMBH METASUL HEAD HIP IMPL WIN Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative

X-rays and surgical report were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).

 
Event Description

Patient was implanted on the left side and underwent revision due to elevated metal ions levels.

 
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Brand NameMETASUL HEAD HIP IMPL WIN
Type of DeviceMETASUL HEAD HIP IMPL WIN
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key10137654
Report Number0009613350-2020-00249
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/12/2020
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: 06/10/2020 Patient Sequence Number: 1
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