MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CENTRAL CONE SIZE FIXED TIBIA; PROSTHESIS, KNEE

Catalog Number	42545000508
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10-medical product variable stiffness stem ext bowed precoat 16 mm diameter 190 mm length; item# 00585207416 lot# 63061848.Segment with male/female taper 30 mm length ; item# 00585004603 lot# 66519809.Distal femoral xt component size c right item# 00585004302 lot# 66701101.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.
Event or Problem Description
It was reported that a patient is being considered for a dfr to arcos stem conversion.The patient previously had zss components implanted, however the patient¿s bone quality is not sufficient for cement fixation.The patient originally had a zss cemented stem implanted, it became loose and then another zss cemented stem was re-implanted, and now the current indwelling cemented stem is also loosening.The surgeon is requesting a custom zss to arcos adapter to mate with the current indwelling zss femur to replace the current indwelling cemented zss stem with a splined arcos stem.Surgeon does not want to revise the well-fixed tibial implants and is just requesting a custom zss to arcos adapter to mate with the zss femoral component and an arcos stem.The tibial cone from the current indwelling is implanted on the femoral side through the femoral stem, therefore, the tibial components on the tibial side are not going to be replaced, but the one on the femoral side will be removed.It is thought that the surgeon implanted it on the femoral side to try and aid in getting the stem to remain fixed.The targeted revision date is early november.Attempts to obtain additional information have been made; however, no more information is available.

• Brand Name: TIBIAL CENTRAL CONE SIZE FIXED TIBIA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25813709
• Report Number: 0001822565-2026-02565
• Device Sequence Number: 14943393
• Product Code: JWH
• UDI-Device Identifier: 00889024560659
• UDI-Public: (01)00889024560659(17)341206(10)66939307
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2026

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: Lay User/Patient
• Device Catalogue Number: 42545000508
• Device Lot Number: 66939307
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male