MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE C 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number	42-5282-003-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: unknown cement: catalog#ni, lot#ni.Report source: foreign: (b)(6).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent an initial partial right knee arthroplasty.Six months post implantation, the patient returned reporting pain.Images showed evidence of cement that had broken apart behind the tibial tray.During the surgery, it appeared that the patient had some further degeneration in the knee and cement was seen in the joint.During the revision, the surgeon removed the articular surface, cleaned out the knee of cement debris, and implanted a new articular surface.The surgeon reported the reason for revision as pain, chondral degeneration and cementophite.The cement used was not zimmer biomet cement.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
Visual examination of the provided picture identified an articular surface with foreign material on it and three unknown foreign bodies.The rim of the articular surface appears to be damaged (gouged), no other definitive statements can be made.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: implants are anatomically aligned, no fracture is present, bone quality is osteopenic, multiple cement fragments are seen, no evidence of loosening, chondral degeneration cannot be confirmed 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: associated medical products: partial tibial cemented size c right medial: catalog#42538000302, lot#64427216; partial femur cemented size 3 right medial: catalog#42558000302, lot#64767076; copal g + c bone cement: catalog#66041214, lot#95374959.Additional information provided does not alter previously reported investigation results.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 or Problem Description
No further event information at time of this report.

• Brand Name: PARTIAL ARTICULAR SURFACE RIGHT MEDIAL SIZE C 8 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12633049
• Report Number: 0001825034-2021-02869
• Device Sequence Number: 19695826
• Product Code: HSX
• UDI-Device Identifier: 00880304817999
• UDI-Public: (01)00880304817999(10)250521(17)64660713
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 42-5282-003-08
• Device Catalogue Number: 42528200308
• Device Lot Number: 64660713
• 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: 09/24/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 07/12/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 02/01/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Female