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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, JJ/36 DURASUL ALPHA INSERT

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ZIMMER GMBH DURASUL, ALPHA INSERT, JJ/36 DURASUL ALPHA INSERT Back to Search Results
Model Number N/A
Device Problem Misassembled
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the explanted devices, the device history records were reviewed and found to be conforming. 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

The inlay could not be anchored into the cup resulting in a delay of 40 min.

 
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Brand NameDURASUL, ALPHA INSERT, JJ/36
Type of DeviceDURASUL ALPHA INSERT
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 Key8154599
Report Number0009613350-2018-01215
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number01.00013.710
Device LOT Number2962348
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2018
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: 12/12/2018 Patient Sequence Number: 1
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