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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH DURASUL CLS SPOTORNO, INSERT, 58/32

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ZIMMER GMBH DURASUL CLS SPOTORNO, INSERT, 58/32 Back to Search Results
Model Number N/A
Device Problems Failure To Adhere Or Bond (1031); Device-Device Incompatibility (2919)
Patient Problem No Information (3190)
Event Date 05/22/2017
Event Type  Injury  
Manufacturer Narrative

The device was received, the investigation is pending. The device history records were reviewed and found to be conforming. Additional information has been requested and is currently not available. 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 that the patient underwent revision surgery on (b)(6) 2017 to replace the inlay on the right side. The new inlay could not be inserted, therefore another cup was used instead. The inlay was not implanted.

 
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Brand NameDURASUL CLS SPOTORNO, INSERT, 58/32
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 Key6809868
MDR Text Key83220614
Report Number0009613350-2017-01087
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number0100307458
Device LOT Number2860805
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2016
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: 08/22/2017 Patient Sequence Number: 1
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