• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E HIP PROSTHESIS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. G7 OSSEOTI 3 HOLE SHELL 52MM E 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 05/10/2018
Event Type  Malfunction  
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 # 010000857, liner, lot # 6238031, item # 010000935, liner, lot # 6183580. (b)(6). Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-03736, 0001825034-2018-03737.

 
Event Description

It was reported that multiple liners would not seat properly into the cup. Surgery was finished with backup liner and cup. Attempts have been made, and no further information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameG7 OSSEOTI 3 HOLE SHELL 52MM E
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 Key7564833
MDR Text Key109900164
Report Number0001825034-2018-03735
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberPK140669
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number110010244
Device LOT Number6250529
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/20/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-