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U.S. Department of Health and Human Services

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

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ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM ACETABULAR COMPONENT HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 01/22/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ldh head hip impl win gen; catalog#: unknown; lot#: unknown. Ldh sleeve hip impl win gen; catalog#: unknown; lot#: unknown. Therapy date: (b)(6) 2021. The manufacturer did not receive devices, x-rays, or other source documents for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. While a cause for this specific event cannot be ascertained from the information provided, the common clinical presentation and the date of the original implantation suggest that this case is related to the issues for which zimmer implemented a notification in july 2008 as referenced above in recall number. Should additional information become available and / or the device(s) be returned for evaluation and an investigation result becomes available, that changes this assessment, an amended medical device report will be submitted. The need for further corrective measures is not indicated at this time. (b)(4).
 
Event Description
Patient was implanted on an unknown side and underwent a revision surgery due to unknown reasons.
 
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Brand NameDUROM ACETABULAR COMPONENT
Type of DeviceHIP PROSTHESIS
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 Key11278341
MDR Text Key230234987
Report Number0009613350-2021-00066
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 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/07/2021
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: 02/04/2021 Patient Sequence Number: 1
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