• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEADS Back to Search Results
Model Number N/A
Device Problem Misassembled
Event Date 10/27/2014
Event Type  Injury  
Manufacturer Narrative

The manufacturer did not receive the device for investigation. Surgical reports were provided for review and will be reviewed within investigation. Where lot number were received for the device, 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 additional information become available and/or an investigation result be available, an amended medical device report will be submitted. Zimmer's reference number of this file is (b)(4).

 
Event Description

A product liability claim was raised. It was reported that the patient was implanted a biolox delta, ceramic femoral head, m, 36/0, taper 12/14 on (b)(6) 2014 on the right side and was revised on (b)(6) 2014 due to alleged mismatch of prosthetic components, instability and pain. The liner was replaced. Note: this is a splitcase with zimmer inc. , (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
Type of DeviceBIOLOX DELTA CERAMIC FEMORAL HEADS
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
kevin escapule
1800 west center street
warsaw , IN 46580
8006136131
MDR Report Key6423681
Report Number0009613350-2017-00412
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 03/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-8775-036-02
Device LOT Number2738353
OTHER Device ID Number00889024430365
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2014
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: 03/22/2017 Patient Sequence Number: 1
-
-