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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 54MM F HIP PROSTHESIS

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ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 54MM F HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem Bone Fracture(s) (1870)
Event Date 04/02/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item# 010000984 g7 freedom constrained e1 liner 36mm f lot# 6159284. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 02579.

 
Event Description

During a total hip arthroplasty the physician had difficulty seating the liner in the cup. Patient experienced fractured pelvis during the attempt to seat the liner. Additional information requested and received.

 
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Brand NameG7 OSSEOTI 4 HOLE SHELL 54MM F
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 Key7469954
MDR Text Key106830139
Report Number0001825034-2018-02578
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK140669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number110010245
Device LOT Number6222888
OTHER Device ID Number(01) 0 0880304 54420 8
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/06/2018
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

Patient TREATMENT DATA
Date Received: 04/27/2018 Patient Sequence Number: 1
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