MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN TIBIAL TRAYS; PROSTHESIS KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Ambulation Difficulties (2544); Tissue Breakdown (2681)

Event Date 11/22/2021

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure post implantation due to pain and range of motion in knee.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 filled to relay additional information, which was unknown at the time of the initial medwatch.A5: race: caucasian.D10 - medical product: femur cemented posterior stabilized (ps) narrow right size 4 catalog # 42500005602, lot # 63636728.All poly patella cemented 29 mm diameter catalog # 42540000029, lot # 64087375.Heraeus bone cement catalog # 5036963, lot # 87904717.Articular surface fixed bearing posterior stabilized (ps) right 10 mm height catalog # 42521400410, lot # 63156950.

Event Description

It was reported patient underwent a revision procedure three years post implantation due to pain, gait impairment, difficulty walking, implant loosening, soft tissue damage, and bone loss in knee.During the revision significant synovitis, gross loosening of the tibia, and necrotic debris were noted.The tibia and articulating surface were replaced without complications.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: UNKNOWN NEXGEN TIBIAL TRAYS
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18309617
• MDR Text Key: 330230204
• Report Number: 0001822565-2023-03542
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female