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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT ALLOCLASSIC SHL 56/KK ALLOFIT ACETABULAR SYSTEM

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ZIMMER GMBH ALLOFIT ALLOCLASSIC SHL 56/KK ALLOFIT ACETABULAR SYSTEM Back to Search Results
Model Number N/A
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2018
Event Type  Malfunction  
Manufacturer Narrative

The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. 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

It was reported that a cup did not sit straight on the impactor. A second cup had to be used and implanted to complete surgery. Attempts to obtain additional information have been made; however, no more is available.

 
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Brand NameALLOFIT ALLOCLASSIC SHL 56/KK
Type of DeviceALLOFIT ACETABULAR SYSTEM
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 Key7272481
MDR Text Key100427169
Report Number0009613350-2018-00250
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberPK003758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00000004247
Device LOT Number2929116
OTHER Device ID Number00889024166042
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2017
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

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