• 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. SHELL POROUS WITH MULTI HOLES 62 MM PROSTHESIS, HIP

  • 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. SHELL POROUS WITH MULTI HOLES 62 MM PROSTHESIS, HIP Back to Search Results
Catalog Number 00620206220
Device Problems Unstable (1667); Malposition of Device (2616); Osseointegration Problem (3003); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Osteolysis (2377)
Event Date 06/23/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device will not be released by hospital. The investigation is in process. Once the investigation is complete, a follow ¿up mdr will be submitted. Concomitant medical products: item# unknown / unknown bone screw / lot # unknown/quantity 5. Item# 00631006236/ tm mod liner 36mm/ lot # unknown. Item# unknown/ unknown allo-pro femoral stem/ lot# unknown. Item# unknown/ unknown competitor head/ lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -02423. 0001822565 -2020 -02427. 0001822565 -2020 -02428. 0001822565 -2020 -02429. 0001822565 -2020 -02430.

 
Event Description

It was reported patient underwent right hip revision surgery 9 years post implantation due to shell loosening and instability. Shell, liner, screws and competitor head were revised. Attempts have been made and additional information on the reported event is unavailable at this time.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSHELL POROUS WITH MULTI HOLES 62 MM
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 Key10242404
MDR Text Key197925822
Report Number0001822565-2020-02422
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093561
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 09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00620206220
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 Received09/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 07/07/2020 Patient Sequence Number: 1
-
-