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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED G7 SHELL HIP PROSTHESIS

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ZIMMER BIOMET, INC. BIOMET FINNED G7 SHELL HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Information (3190)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 010000811, liner, lot # 6065078; item # 010000819, liner, lot # 6029243. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-01866, 0001825034-2018-01867, 0001825034-2018-01868.

 
Event Description

It was reported that multiple liners would not lock into the shell. The event occurred during a primary hip surgery causing a delay greater than 30 minutes. Attempts have been made, and no further information has been provided.

 
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Brand NameBIOMET FINNED G7 SHELL
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 Key7346625
MDR Text Key102716954
Report Number0001825034-2018-01866
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK142746
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 11/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number110017104
Device LOT Number6061019
OTHER Device ID Number(01) 0 0880304 67211 6
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/23/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/16/2018 Patient Sequence Number: 1
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