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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS PROSTHESIS HIP

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ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problem Difficult To Position
Event Date 04/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It is reported that during an initial surgery the trabecular metal shell could not be connected with holder so that the shell failed to be implanted. The surgery is completed with another larger size product.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Updated: complaint sample was evaluated and the reported event was confirmed. Visual review shows bone debris on the exterior surface, scratches to the face of the item around the scallops, scratches and gouges on the tapered angle inside the cup. Specific damage of the square inserter shows a large gouge on the edge of square pocket, gouge near threads, a circle indentation around the entire square pocket. All dimensions checked passed. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
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Brand NameSHELL WITH CLUSTER HOLES POROUS 58 MM O.D. SIZE LL FOR USE WITH LL LINERS
Type of DevicePROSTHESIS HIP
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 Key7537122
Report Number0001822565-2018-02665
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00875705801
Device LOT Number62145977
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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