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

Catalog Number 42530006701

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Rash (2033); Swelling (2091); Sleep Dysfunction (2517); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/15/2015

Event Type  Injury  

Event Description

It is reported that the patient is experiencing a rash, pain, swelling and soreness.

Manufacturer Narrative

The part numbers and lot numbers are unknown; therefore, the device history records could not be reviewed.These devices are used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

A review of the primary surgical notes did not indicate any complications.Post-operative office visits give mention of persistent increasing pain and restrictions of motion despite rehabilitation therapy.Patient received a manipulation on (b)(6) 2015 and after that, full range of motion was achieved.A review of the x-rays shows the devices to be in good position; however; zimmer-biomet employees are not health care professionals and are unable to provide medical advice based on x-rays.The package insert states "poor range of motion" and "pain" as adverse effects of the surgical procedure.This is therefore a known inherent risk of the procedure.A definitive root cause cannot be determined with the information provided.These devices are used for treatment of patients.A product history search did not reveal any other complaints against any of the component part and lot number combinations.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.Concomitant medical product: persona modular tibia, cat#: 42530006701 lot#: 62545292.Persona ultracongruent articular surface fixed bearing, cat#: 42511200416 lot#: 62208308.

Event Description

Upon additional information, it was reported following an initial knee arthroplasty, the patient was revised due to pain, swelling, and soreness.

Manufacturer Narrative

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

It was reported the patient underwent a left knee arthroplasty.Subsequently, the patient experienced rash, stiffness, pain, swelling, difficulty using stairs, soreness, and the patient uses a cane to ambulate.It was noted in the operative reports that the rash was not an allergic reaction, but a reaction from the initial procedure.The patient did physical therapy approximately three months post-implantation.Subsequently, the patient underwent a manipulation procedure under anesthesia approximately four months post-initial implantation.Post manipulation procedure, the patient was still experiencing stiffness, limp, swelling, difficulty sleeping, decreased range of motion, and having to ambulate with a cane.Patient continued to do physical therapy.Subsequently, the patient underwent a revision procedure approximately seven months post-initial implantation.The tibial tray and articular surface were removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.As the femoral component was not revised, this document now reports the tibial component primarily.Reported event was confirmed through medical records received.Visit notes for patient on (b)(6) 2015 under radiographic data states: ¿x-rays of the patient¿s left knee showed a well seated, well aligned left total knee arthroplasty.Mild anterior subsidence.¿ post-operative office visits give mention of persistent increasing pain and restrictions of motion despite patient followed the recommended rehabilitation therapy.Patient received a manipulation for arthrofibrosis of the knee on (b)(6) 2015 and after that, full range of motion was achieved.Dermatologist visit notes from (b)(6) 2015 states there was no indication of an allergic response to the metal hardware.Findings on exam were most consistent with normal inflammatory response s/p a surgical procedure.The patient has improved with topical steroid, further suggesting that the skin findings were post-inflammatory and not an allergic response.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause remains 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

This follow-up report is being submitted to relay additional information.Medical products - nexgen complete knee solution, trabecular metal standard primary patella - catalog #: 00587806532 lot #: 62661486.

Event Description

It was further reported through patient's medical records that the patient underwent a revision due to loosening of the tibial tray.The tibial tray and articular surface were removed and replaced.A tibial stem was also implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the patient underwent a manipulation under anesthesia due to limited range of motion.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the tibial loosening is attributed to a 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.

Event Description

No additional event information to report at this time.

• Brand Name: PERSONA PEGGED POROUS TIBIAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 0708
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 4861496
• MDR Text Key: 5862480
• Report Number: 1822565-2015-00945
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 42530006701
• Device Lot Number: 62545292
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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 Age: 60 YR
• Patient Weight: 98