MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENTAL DIST FEM SIZE B RT; PROSTHESIS, KNEE

Catalog Number	00585001202
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient required a revision surgery due to loosening of the femoral implant about two years and four months post implantation.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10: 00585001295, polyethylene insert size b lot# 62444515.00585002012, articular surface w/segmental hinge post size b 12mm lot# 63955583.00585004645, segment with male/female taper 45 mm lot# 63755779.00585204030, stem collar 30 mm o.D.For use with 16 mm lot# 64034180.00585207416, var stiffness stem ext bowed precoat 16 mm dia 190 mm l lot# 63344473.00585207417, var stiffness stem ext bowed precoat 17 mm dia 190 mm l lot# 63028906.00588000200, size 2 precoat cemented tibial component lot# 64105125.00598801010, 10mm diameter 100mm l straight stem ext length 145mm lot# 64089494.G2: australia.H6: suggested code (annex g)- mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, d2b, d9, g1, g3, g6, h1, h2, h3, h6, and h11 corrected: b5, d5, h4 no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ap view of the knee and lateral views of the right femur show postoperative changes of total knee arthroplasty with distal femoral replacement component and long stem tibial component.There is marked diffuse radiolucency surrounding the bone cement interface of the femoral stem with an associated cement mantle fracture and subsidence of the femoral stem, compatible with loosening.Radiographic osteopenia is noted.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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 the patient underwent a revision approximately six years and four months post-implantation due to loosening of the femoral implant.

• Brand Name: SEGMENTAL DIST FEM SIZE B RT
• 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: 23435190
• Report Number: 0001822565-2025-03925
• Device Sequence Number: 17332951
• Product Code: KRO
• UDI-Device Identifier: 00889024195615
• UDI-Public: (01)00889024195615(17)281231(10)77008684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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 Catalogue Number: 00585001202
• Device Lot Number: 77008684
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2019
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female