MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 12MM; PROSTHESIS, KNEE

Catalog Number	00585003012
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 associated products: 00585001396 polyethylene insert xt size c lot# 66309543.
Event or Problem Description
It was reported the patient was revised due to a fractured segmental hinge post and dislocation.Initial surgery date is unknown.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d5, g3, g6, h1, h2, h3, h6, h10, h11.D10: additional associated products: 00585001396; polyethylene insert xt size c; lot# 66309543.00588000600; size 6 precoat cemented tibial component; lot# 65346357.00598801212; 12.7mm diameter 30mm l st stem length 75mm; lot# 65270143.00585004301; distal femoral xt component size c; lot# 66651240.00585004605; segment with male/female taper 50 mm length; lot# 65623591.00585004603; egment with male/female taper 30 mm length; lot# 66552395.00585204035; stem collar 35 mm o.D.; lot# 66134117.00585205015; fluted stem ext straight 15mm dia 130mm l; lot# 66054698.Visual examination of the provided images reveals that both devices, the hinge post, are fractured, various fragments are shown in the picture and the devices are disassembled.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.This compliant can be confirmed based on the provided picture.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 12MM
• 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: 21655375
• Report Number: 0001822565-2025-00697
• Device Sequence Number: 9246049
• Product Code: KRO
• UDI-Device Identifier: 00889024195745
• UDI-Public: (01)00889024195745(17)300301(10)65244819
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 00585003012
• Device Lot Number: 65244819
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 181 KG