MAUDE Adverse Event Report: Zimmer Biomet, Inc. RHK 10MM FULL BLK TIB AUG SZ3; Prosthesis, Knee

Catalog Number	00588000310
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left knee surgery.Approximately 4.6 years post-implantation a revision due to tibial loosening and a broken cement mantle.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: 00588000302- tib plate sz3 pmma non modular- 63539327.00588003020 - 20mm height size c articular surface with hinge post extension / use with plate 2,3,4,5,6 / screw enclosed do not discard - 63843248.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: RHK 10MM FULL BLK TIB AUG SZ3
• 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 ; +1(574)526-0384
• MDR Report Key: 50948295
• Report Number: 0001822565-2026-03307
• Device Sequence Number: 9499281
• Product Code: JWH
• UDI-Device Identifier: 00889024199019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 09/30/2026

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: 00588000310
• Device Lot Number: 63606679
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2017
• 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