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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, 52/ 46, CODE L

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 52/ 46, CODE L Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01. 00185. 145; lot#: unknown. Metasul ldh, head, 46, code l, taper 18/20; catalog#: 01. 00181. 460; lot#: unknown. Therapy date: unknown. The manufacturer did not receive devices, x-rays, or other source documents for review, as the patient is currently being monitored and has not been revised to date. As no lot numbers were provided for the devices, the device history records could not be reviewed. The cause for this specific event cannot be ascertained from the information provided, as the patient has not been revised. The common clinical presentation and the date of the original implantation suggest that this case might be related to the issues for which zimmer implemented a notification in july 2008 as referenced. Should additional information become available and / or the device(s) be returned for evaluation and an investigation result is available, an amended medical device report will be submitted. Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on the left side and started experiencing pain. Patient is confined to the wheelchair as the pain is unbearable. The patient has not been revised yet.
 
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Brand NameMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 52/ 46, CODE L
Type of DeviceMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED
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 Key10747603
MDR Text Key213426017
Report Number0009613350-2020-00512
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2011
Device Model NumberN/A
Device Catalogue Number01.00214.052
Device Lot Number2362837
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 Received04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2006
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: 10/28/2020 Patient Sequence Number: 1
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