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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Medical product - persona vivacit - e highly crosslinked polyethylene articular surface catalog# (b)(4) lot# 62725626, persona trabecular metal cruciate retaining porous femur catalog#(b)(4) lot# 62844146.

Event Description

Legal counsel for patient who underwent a total knee arthroplasty approximately 2 years ago reported patient allegations of tibial loosening.Patient was revised approximately 1 year ago.This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned tibial component noted one of the pegs was cut and tibial component's surfaces have foreign material attached, along with scratches, and abrasions.Review of the initial surgery operation notes found no deviations in the surgical technique used.From revision surgery operative report, it was noted that the femoral and tibial implants were removed with osteotomes and a reciprocating saw, and the tibial component was found to be grossly loose.Device history record was reviewed with no discrepancies were found.Product recall was initiated in which zimmer voluntarily removed the persona trabecular metal implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.Based on the information available, the root cause can be determined as a previous addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6106271
• MDR Text Key: 60016655
• Report Number: 0001822565-2016-03863
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42530007102
• Device Lot Number: 62664310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR