MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); 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); Radiolucent Lines (4848); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately three years eight and a half months post implantation due to femoral and tibial implant loosening.Right knee aspiration was performed, and the reported results indicated no infection.No medical records or outcomes have been provided.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10-medical product: femoral component option size d right, item# 00596401452, lot# 64081856.Unknown nexgen articular surface.G2- united kingdom.H3- customer 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; h6; h10 - no product was returned or pictures provided; visual and dimensional evaluations could not be performed.- review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.- medical records were provided and reviewed by a health care professional and identified the following: results of ct noted to be tibial and femoral loosening and infection should be considered; patient reported worsening right knee pain, swelling - a definitive root cause cannot be determined.- complaint is confirmed with the provided medical records.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 information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.D10- medical product: articular surface size cd 9 mm height.Item# 00596403009.Lot# 61745503.Palacos cement x2.Item# 66017569.Lot# 89794693.
Event or Problem Description
It was reported that a patient was revised approximately three years eight and a half months post implantation due to femoral and tibial implant loosening.During the revision the tibial component was noted to be loose with no cement attached to baseplate and osteolytic tissue was removed.The femoral component was well fixed.Revision was completed without complications.Right knee aspiration was performed, and the reported results indicated no infection.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, and h11.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: follow-up: pain and swelling, still limping.Rom flexion 90.Xray shows no evidence of periprosthetic fracture or loosening.Continue to extension exercises.Subsequently, the tibial component is loose and removed with no debridement of cement and no cement attached to baseplate, very thin anteromedially.Large synovectomy to remove osteolytic tissue.Femoral component well fixed, explanted with minimal bone loss.A definitive root cause cannot be determined.This complaint is confirmed with the medical records 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 information is available at the time of this report.

• Brand Name: STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 3
• 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: 19794109
• Report Number: 0002648920-2024-00235
• Device Sequence Number: 4133916
• Product Code: JWH
• UDI-Device Identifier: 00889024218833
• UDI-Public: (01)00889024218833(17)280531(10)64055718
• 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: 2022
• 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,Followup
• Report Date (Section B): 08/28/2025

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: 00598603701
• Device Lot Number: 64055718
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 03/14/2025; 08/20/2025
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/31/2024; 04/03/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2018
• 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; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 88 KG