MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN TIB POR 0 DEG SPK KEL E LT; PROSTHESIS, KNEE

Catalog Number	42535007101
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Radiolucent Lines (4848); Aseptic loosening (4883)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42502806401, psn fem cr por ccr std sz 8 l, lot 66704643.42512000510, articular surface fixed bearing cruciate retaining (cr) left 10 mm height, lot 66197112.G2: the event occurred in japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 approximately 4 months post implantation of a left knee total arthroplasty, the patient experienced pain.X-rays were taken and identified tibial component loosening, and radiolucent lines to the distal femoral side.The patient has been indicated for a future revision.Attempts for additional information have been made and none is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b4, b5, g3, h2, h3, h6, h10 the following section was corrected: h4 the reported event was confirmed via medical records.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.X-rays were provided and reviewed by a healthcare professional; they state that the left knee arthroplasty with noncemented components shows diffuse radiolucency around the tibial tray and tibial stem, consistent with tibial component loosening.A new small focal lucency is present beneath the anterior femoral component, although there is no gross evidence of femoral component loosening.A definitive root cause cannot be determined.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 additional information to report.

• Brand Name: PSN TIB POR 0 DEG SPK KEL E LT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 22723516
• Report Number: 3007963827-2025-00305
• Device Sequence Number: 8989910
• Product Code: JWH
• UDI-Device Identifier: 00889024631922
• UDI-Public: (01)00889024631922(17)341025(10)66984332
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221479
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: Lay User/Patient
• Device Catalogue Number: 42535007101
• Device Lot Number: 66984332
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2024
• 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: Other
• Patient Sex: Male
• Patient Weight: 86 KG