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

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: femur trabecular metal cruciate retaining (cr) standard porous, catalog #: 42502806602, lot #: 62573826; natural tibia trabecular metal two-peg porous fixed bearing right size f, catalog #: 42530007502, lot #: 62434349; nexgena complete knee solution, trabecular metal standard primary patella, catalog #: 00587806538, lot #: 62536481.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03839 and 0001822565-2018-03841.Remains implanted.

Event Description

It was reported the patient underwent a right total knee arthroplasty.Subsequently, the patient's legal counsel reports allegations of pain, swelling and multiple flare ups which cause the patient to limp and use a cane to ambulate.Revision procedure is indicated; however, no revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product not returned by patient.

Event Description

It was reported the patient underwent a right initial knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately four years post-implantation due to tibial subsidence of 5-6mm due to possible lack in anterior cortical rim coverage.It was further noted that the tibia was thought to be loose/unstable.Operative reports indicate that the patient has a history of effusion in the knee which is most likely due to rheumatoid arthritis.The patient was also noted to have pain, swelling and discomfort in the right knee and the patient is unable to walk long distances.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).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.Medical records were provided and reviewed by a health care professional and identified no significant findings.No statements about the bone quality during the primary surgery were noted during the review.Operative notes from the revision surgery were not provided.Assessment of the provided x-rays identified subsidence of the anterior aspect of the tibial component and apparent loosening of the tibial component.A definitive root cause cannot be determined.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

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified signs of being implanted (scratched and foreign material in tm pad) and the posts are cut off.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA - NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7781353
• MDR Text Key: 117123043
• Report Number: 0001822565-2018-03842
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530007502
• Device Lot Number: 62434349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other