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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 54MM F PROSTHESIS, HIP

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ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 54MM F PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert
Event Date 01/20/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Reported event was confirmed by review of visual evaluation of the returned product. The shell had scratches on the inner radius. The rim has similar dings from a removal tool as were found on the liner. Dimensional analysis not performed as impaction and product damage may interfere with accuracy of readings. Device history record (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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00620.

 
Event Description

It was reported during surgery, the liner would not assemble with the acetabular shell. This surgery was finished with backup product. No further event information available at the time of this report.

 
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Brand NameG7 OSSEOTI MULTIHOLE 54MM F
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 Key10130777
Report Number0001825034-2020-02264
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number110010265
Device LOT Number6627145
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/17/2019
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

Patient TREATMENT DATA
Date Received: 06/08/2020 Patient Sequence Number: 1
Treatment
BIOMET G7 E1 LINER CAT#010000850 LOT#6631203
UNKNOWN HEAD
UNKNOWN STEM
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