MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TWO PEG POROUS TIBIAL COMPONENT; KNEE, PROSTHESIS

Catalog Number 42530007901

Device Problems Migration or Expulsion of Device (1395); Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Pain (1994); Synovitis (2094); No Information (3190)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the patient underwent a knee arthroplasty revision procedure due to unknown reasons.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: femur cemented posterior stabilized (ps) standard left size 10 catalog# 42500606801 lot # 62693693.Articular surface fixed bearing posterior stabilized (ps) left 11 mm height catalog# 42511401011 lot# 62265669.All poly patella cemented 32 mm diameter catalog# 42540000032 lot# 62587958.Palacos r 1x40 single catalog# 00111214001 lot# 78434385.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.The following sections have been updated: 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-03604, 3007963827-2017-00249, 0002648920-2017-00517, 0001822565-2017-05951.

Event Description

It was reported the patient underwent a left total knee arthroplasty.Subsequently, the patient experienced pain approximately five months post-implantation.The patient underwent a revision procedure approximately six months post-implantation due to pain and loosening of the tibial component.Operative reports indicate that during the procedure the patient had large effusion that was serosanguineous.The patient had tremendous synovitis in the joint.The surgeon removed this.The tibial tray was noted to have lack of bony ingrowth.The femoral component was also noted to be loose.Finally the patella component had large osteophytes all the way around it.The patella component remained implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: PERSONA TWO PEG POROUS TIBIAL COMPONENT
• 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: 6004140
• MDR Text Key: 56597695
• Report Number: 0001822565-2016-03604
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42530007901
• Device Lot Number: 62692165
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR