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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 52/46 L DUROM ACETABULAR COMPONENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 52/46 L DUROM ACETABULAR COMPONENT Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)
Patient Problems Necrosis (1971); Scar Tissue (2060); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 01/18/2018
Event Type  Injury  
Event Description
It was reported that there was a revision due to metallosis.
 
Manufacturer Narrative
Concomitant medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20: catalog#: 0100185145, lot#: 2408138; metasul ldh, head, 46, code l, taper 18/20: catalog#: 0100181460, lot#: 2408358. Therapy date: (b)(6) 2018. Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer. Zimmer gmbh (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department. As soon as supplemental information becomes available an updated report will be submitted. The manufacturer received surgical reports and legal documents and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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).
 
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Brand NameDUROM US ACET CMPNT 52/46 L
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 Key13759243
MDR Text Key287185971
Report Number0009613350-2022-00147
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number01.00214.152
Device Lot Number2403856
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
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 Number9613350-07/15/2008-001C

Patient Treatment Data
Date Received: 03/14/2022 Patient Sequence Number: 1
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