MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT; 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); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: nexgen femoral component catalog # 00576401552 lot # 63892721; nexgen articular surface catalog # 00596403210 lot # 63885747; nexgen all poly patella catalog # 00597206532 lot # 64008718.G2: united kingdom.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2024-00081; 0001822565-2024-00358; 0002648920-2024-00082.
Event or Problem Description
It was reported patient is experiencing unknown issue post implantation.No revision procedure has been reported to date.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Review of the device history record identified deviations or anomalies during manufacturing.However, it is unknown if they are related to the reported event, as the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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 filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
It was reported patient underwent a revision procedure five years post implantation due to massive osteolysis and loosening of the tibial component without attachment of cement to the baseplate.Attempts to obtain additional information have been made; however, no more is available.
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/corrected: updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h11.Medical records received.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records provided and reviewed state that the patient underwent a right total knee arthroplasty (tka) ana bout a week later the joint displayed increased warmth.Over the following years, the patient experienced persistent swelling, pain, and stiffness, with documented complaints of entire leg swelling since surgery and ongoing pain.An ultrasound about one year later noted likely post-operative lymphedema.The patient returned 2 years post visit with a very painful swollen knee, which gradually worsened.A bone scan two years later indicated features felt to represent aseptic loosening, particularly loosening of the tibial component.A year after the most recent visit, the patient underwent a revision procedure.Intraoperatively, massive osteolysis was identified, and the tibial component was loose.The cemented patellar component was retained.All other components were explanted and replaced with competitor products.The patient was discharged on, and at follow-up was noted to be doing well with little swelling and range of motion of 0¿90 degrees.A definitive root cause cannot be determined.However, during the investigation it was identified that competitor devices were implanted with the our devices retained.We have not confirmed the compatibility for this combination of devices.Please note that per the ifu, it states 'hcp should not be mixing the components of the system with components of any other system or manufacturer, unless authorized by us'.Complaint is confirmed based on operative notes provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT
• 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: 18959470
• Report Number: 0002648920-2024-00079
• Device Sequence Number: 9346000
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)280430(10)64021330
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00598603702
• Device Lot Number: 64021330
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 03/12/2025; 08/14/2025
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 07/09/2024; 04/07/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Hispanic
• Patient Race: White