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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/ 48, CODE N DUROM ACETABULAR COMPONENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/ 48, CODE N DUROM ACETABULAR COMPONENT Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problem Osteolysis (2377)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive devices or x-rays for review. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. Based on an extensive investigation of events reported from several user facilities outside the usa, zimmer identified that the most probable cause for the outcome observed was a loose or unstable cup that resulted from use of surgical techniques not consistent with the manufacturer's recommendations. As a corrective action, a retraining program for users outside the usa was initiated in november 2009 and reported to the national competent authorities as required. The durom cup reported in this case is not marketed in the usa. A similar cup, compatible with the metasul ldh femoral head, is cleared in the usa and a corrective action for this product was reported to the fda in july 2008 as notification z-2415/2426-2008. Since this case is related to the issues for which zimmer implemented a corrective action there will be no further investigation. Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on an unknown side and underwent revision surgery due to periacetabular osteolysis.
 
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Brand NameMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/ 48, CODE N
Type of DeviceDUROM ACETABULAR COMPONENT
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 Key10850525
MDR Text Key216597806
Report Number0009613350-2020-00539
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
N/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
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2009
Device Model NumberN/A
Device Catalogue Number01.00214.054
Device Lot Number2194007
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 Received03/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2004
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: 11/17/2020 Patient Sequence Number: 1
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