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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CLS STEM

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ZIMMER GMBH CLS STEM Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

Concomitant medical product: unknown cup, catalog#: unknown; lot#: unknown. Therapy date: unknown. The manufacturer received x-ray and 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 an implant enquiry was made as a part of surgery pre-planning to treat periprosthetic fracture.

 
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Brand NameCLS STEM
Type of DeviceCLS STEM
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER 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 Key10117959
Report Number0009613350-2020-00233
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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 Received05/06/2020
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 Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/04/2020 Patient Sequence Number: 1
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