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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ALLOCLASSIC SL STEM 4 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

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ZIMMER GMBH ALLOCLASSIC SL STEM 4 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 04/02/2019
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: item# 2844, lot# 2930955, alloclassic sl stem 4 12/14. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. The manufacturer did not receive other source documents for review. Device history record (dhr) was reviewed and no discrepancies were found. 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 patient labels were not included in this product package. The event happened during surgery; however, no adverse events have been reported as a result of the malfunction.

 
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Brand NameALLOCLASSIC SL STEM 4 12/14
Type of DeviceALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL 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 Key8560038
Report Number0009613350-2019-00274
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number2844
Device LOT Number2930955
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 Received08/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/11/2018
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

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