MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial bilateral total knee arthroplasty.Approximately 6 years post-op, the patient stated his left knee has failed and was experiencing pain and difficulty weight-bearing.Upon medical evaluation, revision has been recommended but has not been scheduled.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 : 00596401651 - femoral component option size f left compatible with lps-flex prolong - 63476558.00596404012 - articular surface size ef 12 mm height ''use with plate 5 - 64012146 00597206535 - all poly petella standard cemented size 35 mm diameter 9.0 mm thickness - 63971420.600-15-100 - cobalt g-hv bone cement 40gm - 266250.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the patient was revised due to tibial loosening and pain.The femoral and poly components were also revised.The surgeon noted that upon removing the tibia, it had some cement bonded to the surface of the implant with virtually none around the keel.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: a1; b4; b5; b6; b7; d2; e1; g1; g3; g6; h1; h2; h6; h10.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 the patient underwent an initial bilateral knee surgery.Approximately 6 years post-op, the patient underwent a revision due to pain, difficulty walking, and radiographic evidence of aseptic loosening.During the procedure, the surgeon noted the tibial component to be grossly loose and there was extensive osteolysis of the metaphysis of the lateral tibia with an uncontained defect.All components, except the cemented patella were revised without complication.Attempts have been made and all available information has been provided.
Event or Problem Description
No further event information available at the time of this report.
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.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.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.Primary operative notes state that there were no intraoperative complications.Revision operative notes state that the patient was revised due to pain and aseptic loosening.During revision it was found that femoral and patellar components well fixed but the tibial component was grossly loose.There was also extensive osteolysis of the metaphysis of the lateral tibia with uncontained defect.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4; b4; b5; b6; b7; d2; g1; g3; g6; h1; h2; h6 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
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.The event is confirmed.Additional medical records and radiographic images were reviewed by a healthcare professional.Records noted that the patient was experiencing pain, difficulty walking, and moderate effusion.X-rays provided confirmed signs of tibial loosening.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: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION
• 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: 19561047
• Report Number: 0002648920-2024-00194
• Device Sequence Number: 7549951
• Product Code: JWH
• UDI-Device Identifier: 00889024218857
• UDI-Public: (01)00889024218857(17)280430(10)64008418
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/21/2025

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: N/A
• Device Catalogue Number: 00598604701
• Device Lot Number: 64008418
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 11/06/2024; 11/20/2024; 12/10/2024; 04/21/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/23/2024; 11/14/2024; 11/24/2024; 12/18/2024; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2018
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 92 KG