MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 12 MM HEIGHT "USE WITH PLATE 3; PROSTHESIS, KNEE

Model Number 5964-32-12

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Arthralgia (2355); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 08/22/2022

Event Type  Injury  

Event Description

It was reported via patient's legal counsel that a patient underwent an initial right total knee arthroplasty.Since implantation the patient has experienced continuous pain and difficulty with mobility.Continuation of prescription pain medication did not relieve the patient's symptoms.Approximately four years post implantation, xray images revealed loosening of the medial tibial plateau and a diagnostic arthroscopy found synovitis from polyethylene abrasion deposits in the joint.Cultures and tissue samples showed no evidence of infection.The patient is scheduled for an upcoming revision surgery due to aseptic loosening and polyethylene bearing wear.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Medical product: stemmed tibial component precoat size 4 for cemented use only: catalog#00598003702, lot#63987026; femoral component option for cemented use only size e: catalog#00599601502, lot#63931769; optipac 60 refob bone cmt r-3: catalog#4711500396-3, lot#729aa03415.Report source: foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated report: 0002648920-2023-00002.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned and pictures provided were insufficient to complete visual and dimensional evaluations.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no patellar resurfacing/implant, discharge report states procedure and post-op stay went well without complications, post-op x-ray shows implants in correction position and alignment, and the patient was able to increase range of motion with rehab discharge.Additionally, patient made good progress with physical therapy.Root cause was unable to be determined.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.

Event Description

No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE SIZE EF 12 MM HEIGHT "USE WITH PLATE 3
• 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: 16132752
• MDR Text Key: 307026602
• Report Number: 0001822565-2023-00065
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024211896
• UDI-Public: (01)00889024211896(17)260131(10)63908007
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5964-32-12
• Device Catalogue Number: 00596403212
• Device Lot Number: 63908007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG