• 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. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING PROSTHESIS KNEE

  • 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. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problems Loss of or Failure to Bond (1068); Migration (4003)
Patient Problem Joint Laxity (4526)
Event Date 03/17/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Medical product: femur cemented cruciate retaining (cr) narrow right size 6 catalog # 42502006002 lot # 64694425. All-poly patella cemented 32 mm diameter catalog # 42540200032 lot # 64776022. Articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 6-7 catalog # 42522100411 lot # 64477748. Tenet knee 2-primary w/ve catalog # 98000630100 lot # unknown. Customer has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient experienced tibial loosening and migration of the implant several months later. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING
Type of DevicePROSTHESIS KNEE
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 Key11739284
MDR Text Key247788855
Report Number0001822565-2021-01163
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173417
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 05/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530006702
Device LOT Number64804226
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 Received05/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/07/2020
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: 04/28/2021 Patient Sequence Number: 1
-
-