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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM ACETABULAR COMPONENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM ACETABULAR COMPONENT Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
Medical product: alloclassic stem hip impl win gen; item# unknown; lot# unknown. The manufacturer did not receive devices or x-rays for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. 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 right side and underwent revision surgery due to pain, difficulty in walking, elevated metal ions and metallosis.
 
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Brand NameDUROM ACETABULAR COMPONENT
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 Key10941756
MDR Text Key219493607
Report Number0009613350-2020-00564
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 consumer,foreign
Reporter Occupation Non-Healthcare Professional
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 Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/03/2020 Patient Sequence Number: 1
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