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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 62MM H L 62MM H PROSTHESIS, HIP

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ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 62MM H L 62MM H PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert
Event Date 03/18/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: biomet g7 10 deg arcomxl liner 40mm h: cat# 010000788, lot# 3787184. The device will not be returned for analysis, per hospital policy; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02006.

 
Event Description

It was reported that during the revision, the osseoti multi shell was implanted per technique without issue. An attempt was made to insert the 10 degree 40mm arc liner per technique. While the liner appeared to the surgeon eye to be satisfactory, a tug on the liner lip immediately resulted in the liner coming out of the shell. After multiple attempts to implant the liner, and after checking the liner for damage, it was determined that the liner was defective. A 10 degree 36mm liner was then implanted, yet same result as the prior liner, no success. The noted shell was removed and a 4 hole osseoti same size was implanted with screws to follow. The 10 degree 36mm liner previously used was inspected for damage and implanted, without issue. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameG7 OSSEOTI MULTIHOLE 62MM H L 62MM H
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 Key10097675
Report Number0001825034-2020-02009
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 05/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number110010269
Device LOT Number6285532
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 Received05/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2018
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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