MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN PATELLA COMPONENT SIZE 41; PROSTHESIS, KNEE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Synovitis (2094); Ambulation Difficulties (2544)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown nexgen femoral component size g: catalog#ni, lot#ni; unknown nexgen tibial tray size 8: catalog#ni, lot#ni; unknown nexgen articular surface 10mm: catalog#ni, lot#ni; unknown bone cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this complaint.Please see associated reports: 0001822565-2022-03347; 0001822565-2022-03348; 0001822565-2022-03349.Customer has indicated that the product is unavailable for return to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, eight(8) years post-implantation, the patient underwent a debridement with a synovial biopsy for pain, difficulty ambulating, limited daily activities and decreased range of motion.During the debridement noted minor wear to the articular surface with erosion of the tip of the bearing and synovitis.The debridement was completed without complication.It was reported that no further information is available.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records shows that the patient experienced pain, range of motion issue after 8 years of the initial surgery.X-rays shows the implant was stable and no fracture.During the debridement procedure, minor pitting and erosion on the articular surface.Also, diffused the synovitis.No complication was noted.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN NEXGEN PATELLA COMPONENT SIZE 41
• 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: 16009555
• MDR Text Key: 305751415
• Report Number: 0001822565-2022-03537
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White