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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Pain (1994)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.Concomitant products: persona articular surface fixed bearing catalog# 42-5112-005-10, lot# 62707946.Persona trabecular metal narrow porous femur catalog# 42-5022-068-01, lot# 62486866.Nexgen complete trabecular metal standard primary patella catalog# 00-5678-065-32, lot# 62640242.

Event Description

Legal counsel for patient who underwent a total knee arthroplasty approximately 26 months ago reported patient allegations of pain.Patient was revised approximately 14 months ago due to pain secondary to instability and tibial component aseptic loosening 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 filed to relay additional information, which was unknown at the time of the initial medwatch.There were no devices or photos received; therefore the condition of the component is unknown.Review of the device history records for the tibial component did not find any deviation or anomalies.The review of the primary operative notes confirms that the patient underwent right total knee arthroplasty for degenerative joint disease and morbid obesity.Review of primary operative notes does not indicate root cause.The notes indicated that there was good medial lateral stability throughout the range of motion.The review of the revision operative stated that the patient underwent revision of left total knee due to instability and suspected tibial component aseptic loosening.The revision notes mentions that the femoral component was well fixed.Upon removal of the tibial component there was minimal evidence of bony in growth noted.There was no compatibility issues noted.A definitive root cause cannot be determined for the loosening of the tibial with the information provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A field action was conducted in which zimmer voluntarily removed the persona trabecular metal tibial implant from the field due to a higher than anticipated complaint rate for radiolucent lines and loosening.The root cause is design deficiency.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

Visual evaluation of the returned tibial component shows nicks and gouges.Additionally, the two peg features were cut off and not returned.The articular surface and femoral component were also returned.Dimensional analysis of the returned tibial component shows that the device is conforming to specification where measured.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 TRABECULAR METAL TWO-PEG POROUS FIXED BEARING TIBIA
• Type of Device: PROSTHESIS, KNEE
• 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 ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6114581
• MDR Text Key: 60412385
• Report Number: 0001822565-2016-04278
• Device Sequence Number: 1
• Product Code: OIY
• 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: consumer,health professional
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 42530007101
• Device Lot Number: 62584835
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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: 57 YR