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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER M/L TAPER FEMORAL STEM HIP PROSTHESIS

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ZIMMER BIOMET, INC. ZIMMER M/L TAPER FEMORAL STEM HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem
Event Date 12/07/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted.

 
Event Description

It was reported that there was missing foil packaging when implant box was opened. When sterile lid was opened, the tip of the stem had broken through the plastic bag it was in. The outer clear hard plastic that the implant sits in was also cracked close to the end of the implant. The outer box and plastic was not compromised in any way. It was only the inner packaging that was damaged. Sterility was compromised.

 
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Brand NameZIMMER M/L TAPER FEMORAL STEM
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7192937
Report Number0001822565-2018-00315
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00771100410
Device LOT Number62868356
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/24/2014
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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