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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CLS SPORTORNO CUP HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH CLS SPORTORNO CUP HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Break (1069); Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
The manufacturer received other source documents for review. The manufacturer did not receive the device for investigation. 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. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
This event is part of a journal article: long-term results of total hip arthroplasty performed using a cementless expansive acetabular cup and spotorno femoral stem. The aim of the study was to investigate the long-term clinical and radiological results, revision rates and causes, and the rate of implant survival in total hip arthroplasty performed using cls expansion cup and spotorno cementless femoral stem. 114 patients participated in the study out of which 39 were males and 75 were females. 8 patients underwent revision surgery due to fracture of the cls spotorno cup.
 
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Brand NameCLS SPORTORNO CUP
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 Key12518757
MDR Text Key272890592
Report Number0009613350-2021-00490
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/25/2021
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: 09/23/2021 Patient Sequence Number: 1
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