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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL CUP

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ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL CUP Back to Search Results
Model Number N/A
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: unknown liner; catalog#: unknown; lot#: unknown. Unknown head; catalog#: unknown; lot#: unknown. Unknown stem; catalog#: unknown; lot#: unknown. Therapy date: unknown. The manufacturer did not receive x-rays, or other source documents for review. As no lot number was provided, the device history records could not be reviewed. 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. (b)(4).
 
Event Description
Patient was implanted on an unknown side and is indicated for the revision surgery due to unknown reasons. It is unknown if the revision surgery has been performed.
 
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Brand NameMETASUL CUP
Type of DeviceMETASUL CUP
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 Key10688529
MDR Text Key211639312
Report Number0009613350-2020-00489
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
Type of Report Initial,Followup,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2020
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 Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
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