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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD

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ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical product: bone screw self-tapping 6. 5 mm dia. 30 mm length; catalog no #: 00-6250-065-30; lot #: 62292642. Constrained liner with constraining ring 36 mm i. D. Size mm for use with 60 mm o. D. Size mm shell; catalog no #: 00-8758-014-36; lot #: 63097134. Therapy date: (b)(6) 2020. The manufacturer did receive per 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. Zimmer biomet¿s reference number of this file is (b)(4).

 
Event Description

Patient was implanted on the unknown side and underwent revision surgery due to instability and noise.

 
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Brand NameBIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
Type of DeviceBIOLOX DELTA CERAMIC FEMORAL HEAD
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING 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 Key10413358
MDR Text Key203117715
Report Number0009613350-2020-00381
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK071535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2020
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 Number00-8775-036-02
Device LOT Number2909462
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 Received12/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/17/2020 Patient Sequence Number: 1
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