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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 40/+3.5, TAPER 12/14

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ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 40/+3.5, TAPER 12/14 Back to Search Results
Model Number N/A
Device Problems Fracture; Noise, Audible
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative

Medical product: liner standard 3. 5 mm offset 40 mm i. D. For use with 58 mm o. D. Shell, catalog# : 00630505840; lot# : 62858013. Therapy date: (b)(6) 2019. 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. Zimmer biomet¿s reference number of this file is (b)(4).

 
Event Description

Patient was implanted on an unknown side and underwent revision surgery due to implant fracture, fluid collection and squeaky noise.

 
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Brand NameBIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 40/+3.5, TAPER 12/14
Type of DeviceBIOLOX DELTA, CERAMIC FEMORAL HEAD
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 Key9580424
Report Number0009613350-2020-00021
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2020
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 Number00-8775-040-03
Device LOT Number2736816
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 Received06/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2014
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: 01/13/2020 Patient Sequence Number: 1
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