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

Catalog Number	00598603701
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Radiolucent Lines (4848)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately six years two and a half months post implantation due to tibial loosening.There is no additional information available.
Additional Manufacturer Narrative
(b)(4).D10- medical product: palacos r+g 2 x 40 item# 66017589.Lot# 86394614.All poly petella standard cemented size 29 mm diameter 8.0 mm thickness item# 00597206529.Lot# 63650839.Articular surface size cd 10 mm height.Item# 00596403010.Lot# 63398354.Femoral component option size d left.Item# 00596401451.Lot# 61722188.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
This follow-up is being submitted to relay additional information.
Event or Problem Description
It was reported that a patient was revised approximately six years and three months post implantation due to femoral and tibial component loosening.During the revision both the tibia and femoral implants were found loose, tibia implant had sunk medially, and osteolysis was noted around the femoral component.There is no additional information.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11 no devices or photos were received; therefore, the condition of the components is unknown.Primary operative notes state that no intraoperative complications were seen.Revision operative notes confirm that tibia and femoral components were loose.The tibial component has sunk medially and osteolysis was seen around femoral.Office notes prior to revision surgery state that the patient was experiencing pain, limited rom, and was struggling to walk.X-rays taken during the office visit state that metal work appears intact, increased lucency at the bone prosthesis interface of the proximal tibia and some subsidence of the prosthesis inferior and distally anteriorly into the tibia, consistent with chronic loosening, heterotopic bone formation noted around the posterior aspect of the joint capsule.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Root cause cannot be determined.This complaint is confirmed via medical record review.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch 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: 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: 21244992
• Report Number: 0002648920-2025-00027
• Device Sequence Number: 15563394
• Product Code: JWH
• UDI-Device Identifier: 00889024218833
• UDI-Public: (01)00889024218833(17)270430(10)63649802
• 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: 2017
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 06/20/2025

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 Catalogue Number: 00598603701
• Device Lot Number: 63649802
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 06/11/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 04/08/2025; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2017
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 78 KG