MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 FOR CEMENTED USE ONLY; PROSTHESIS, KNEE

Model Number	5980-37-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Arthralgia (2355); Inadequate Pain Relief (2388); Ambulation or Postural Difficulties (2544)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface size ef 12 mm height use with plate 3: catalog#00596403212, lot#63908007; 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: 0001822565-2023-00065.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.
Event or Problem 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.
Event or Problem Description
No further event information at time of this report.
Additional 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.

• Brand Name: STEMMED TIBIAL COMPONENT PRECOAT SIZE 4 FOR CEMENTED USE ONLY
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16132756
• Report Number: 0002648920-2023-00002
• Device Sequence Number: 7607945
• Product Code: JWH
• UDI-Device Identifier: 00889024217584
• UDI-Public: (01)00889024217584(17)280430(10)63987026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5980-37-02
• Device Catalogue Number: 00598003702
• Device Lot Number: 63987026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG