MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00598801010 - 10mm diameter 100mm length straight stem extension combined length 145mm - 65573292 00599405010 - 10mm height size g with locking screw blue articular surface use with femoral g / screw enclosed do not discard - 63600733 00599401791 - left size g cemented option femoral component femoral plastic cap must be removed prior to implantation - 64327283 00597206541 - all poly patella standard cemented size 41 mm diameter 10.0 mm thickness - 63208850 00599003701 - posterior femoral augment block precoat may be used with distal and/or anterior blocks size g 5 mm augment with screw - 62737102 00599003720 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size g 10 mm augment with screw - 63114725 00599003701 - posterior femoral augment block precoat may be used with distal and/or anterior blocks size g 5 mm augment with screw - 63668150 00598801014 - 14mm diameter 100mm length straight stem extension combined length 145mm - 64600616 00599003720 - distal femoral augment block precoat may be used with posterior and/or anterior blocks size g 10 mm augment with screw - 64582108 g2 : foreign country : australia customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a knee procedure.Approximately 1 year post-op, the patient was revised due to pain and stiffness.The tibial component, poly, and stem were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10 visual examination of the provided picture identified a metallic tibial component with attached biological material and signs of wear.The device history record was reviewed and no discrepancies relevant 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.X-rays were provided and reviewed by mmi.They state that the left knee arthroplasty is anatomically aligned, with no evidence of implant loosening or fracture.The assessment noted the presence of proximal tibial screws from a tibial tubercle osteotomy.Bone quality was identified as osteopenic.No radiolucency, malalignment, or other abnormalities were detected.However, the report suggests that the proximal tibial screws could potentially contribute to the patient¿s reported pain due to their relationship with the tibial implant or surrounding soft tissue structures.A definitive root cause cannot 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT PRECOAT SIZE 8
• 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: 19995954
• Report Number: 0002648920-2024-00258
• Device Sequence Number: 8363282
• Product Code: JWH
• UDI-Device Identifier: 00889024217638
• UDI-Public: (01)00889024217638(17)280531(10)64048955
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 12/04/2024

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 Model Number: N/A
• Device Catalogue Number: 00598005702
• Device Lot Number: 64048955
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male