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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING L PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ZIMMER PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING L PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Migration (4003)
Patient Problem No Information (3190)
Event Date 12/28/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: palacos rg 1x40 single, catalog #: 00111314001, lot #: 75774319, qty: 2; articular surface fixed bearing posterior stabilized (ps) left 12 mm height, catalog #: 42512400712, lot #: 62197498; femur cemented posterior stabilized (ps) standard left size 8, catalog #: 42500606401, lot #: 62127369; all-poly patella cemented 32 mm diameter, catalog #: 42540200032, lot #: 62235042. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product location unknown.

 
Event Description

It was reported the patient underwent a left total knee arthroplasty. Subsequently, the patient underwent a revision due to loosening of the tibial tray approximately fours years post-implantation. Operative reports further noted that during the revision procedure the patient was also noted to have fibrosis of the left total knee arthroplasty. Furthermore, the patient was noted to have instability prior to the revision procedure which required a brace.

 
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Brand NameZIMMER PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING L
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 Key7741599
MDR Text Key115763974
Report Number0001822565-2018-03587
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007501
Device LOT Number62268137
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/18/2013
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: 08/01/2018 Patient Sequence Number: 1
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