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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, 44¸ 38, CODE D DUROM ACETABULAR COMPONENT

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 44¸ 38, CODE D DUROM ACETABULAR COMPONENT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cyst(s) (1800)
Event Date 11/12/2021
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. 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).
 
Event Description
It was reported a revision surgery due to voluminous pseudotumor from hip debris right.
 
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Brand NameMETASUL DUROM, COMPONENT FOR ACETABULUM, UNCEMENTED, 44¸ 38, CODE D
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 Key12960056
MDR Text Key281909678
Report Number0009613350-2021-00657
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 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2010
Device Model NumberN/A
Device Catalogue Number01.00214.044
Device Lot Number2282455
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2005
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: 12/08/2021 Patient Sequence Number: 1
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