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

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH SULOX, HEAD, M, 32/0, TAPER 12/14

  • 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 SWITZERLAND MANUFACTURING GMBH SULOX, HEAD, M, 32/0, TAPER 12/14 Back to Search Results
Model Number N/A
Device Problem Noise, Audible (3273)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 06/18/2020
Event Type  Injury  
Manufacturer Narrative

The manufacturer received other source documents for review. As no lot number was provided, the device history records could not be reviewed. 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 the left side and started experiencing issues with mobility and rubbing noises.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSULOX, HEAD, M, 32/0, TAPER 12/14
Type of DeviceSULOX, HEAD, M, 32/0, TAPER 12/14
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 Key10272278
MDR Text Key199711561
Report Number0009613350-2020-00317
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberN/A
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 01/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number17.32.06
Device LOT Number2773687
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/22/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2014
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: 07/14/2020 Patient Sequence Number: 1
-
-