MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN OPTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 3; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant devices - nexgen articular surface catalog #: 00596403012 lot #: 63631119, nexgen femoral component catalog #: 00576401452 lot #: 63342343, nexgen patella catalog #: 00597206532 lot #: 63409706, heraeus medical palacos r + g bone cement catalog #: 66017569 lot #: 85964608 g2 - report source - foreign: event occurred in the united kingdom.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.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 the patient underwent a right knee arthroplasty revision to address pain, swelling and ambulation difficulties secondary to loosening and migration of the tibial component approximately five (5) years post-operatively.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Medical records provided confirmed the patient was revised due to tibial loosening.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.
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.
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, b6, b7, g3, g6, h2, h3, h6, h11.Additional medical records were received and reviewed, further confirming the reported event.The root cause remains undetermined.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
It was reported that the patient underwent a right knee arthroplasty revision to address pain, swelling and ambulation difficulties secondary to loosening and migration of the tibial component approximately five (5) years post-operatively.Revision operative notes noted that there was no evidence of cement on the tibial tray when it was removed.No intraoperative complications were noted.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g3, g6, h2, h11.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address pain, swelling and ambulation difficulties secondary to loosening and migration of the tibial component and patella fracture approximately five (5) years post-operatively.All components were revised and replaced.Revision operative notes noted that there was no evidence of cement on the tibial tray when it was removed.No intraoperative complications were noted.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h11.Additional medical records were received and reviewed, confirming the patient was revised due to tibial loosening as well as a vertically oriented stress fracture across the lateral third of the patella.The root cause remains undetermined.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.

• Brand Name: NEXGEN OPTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 3
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
• 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: 20068219
• Report Number: 0002648920-2024-00273
• Device Sequence Number: 12968228
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 00598603701
• Device Lot Number: 63535337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 03/19/2025; 07/15/2025; 09/17/2025; 11/03/2025; 08/17/2026
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 12/06/2024; 04/15/2025; 08/06/2025; 09/29/2025; 11/13/2025; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2016
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 187 LB
• Patient Race: White