• 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 HEAD

  • 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 HEAD Back to Search Results
Model Number N/A
Device Problem Noise, Audible (3273)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products and therapy date. Detail of product: item #: 65875505600; item name: allofit it alloclassic, shell for acetabulum, ha, uncemented, 56/kk; lot #: unknown. As no lot number was provided, the device history records could not be reviewed. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation because it remains implanted. 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

It was reported that patient underwent revision surgery due to noise and an inlay was changed.

 
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 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 Key8031774
MDR Text Key125903927
Report Number0009613350-2018-01121
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
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,Followup
Report Date 01/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2018
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 Number2666121
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/22/2012
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: 11/02/2018 Patient Sequence Number: 1
-
-