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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14

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ZIMMER GMBH REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14 Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: shell with cluster holes porous 60 mm o. D. Size mm for use with mm liners catalog#: 00875706001; lot#: 61297998. Bioloxâ® delta ceramic taper liner, size mm / 36 i. D. For use with 60 mm o. D. Size mm shell catalog#: 00877501436; lot#: unknown. Therapy date: (b)(6) 2020. The manufacturer received other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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. (b)(4).

 
Event Description

Patient was implanted on an unknown side and underwent revision surgery due to pain, metallosis and dislocation.

 
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Brand NameREVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14
Type of DeviceREVITAN, PROXIMAL PART, CONICAL, UNCEMENTED
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 Key10128067
Report Number0009613350-2020-00237
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2015
Device MODEL NumberN/A
Device Catalogue Number01.00401.075
Device LOT Number2558470
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 Received05/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/09/2010
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: 06/08/2020 Patient Sequence Number: 1
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