MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS MOD PROX TIB 9CM; PROSTHESIS, KNEE

Catalog Number	150443
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Journal article provided confirms that the anchor plug is fractured at the base of the anchor plug and during the revision they found out that tibia was fractured.It was reported that fell however the reason for fall is unknown.A definitive root cause cannot be determined.This complaint is confirmed via journal article notes provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that surgery was performed for proximal tibia tumor with oss.Approximately 9 months post operatively, the patient experienced discomfort and fell.The surgeon found that the anchor plug broke.Bone formation was seen on side view, but the bone formation was partially seen on front view from x-rays.Subsequently, a revision was performed on (b)(6) 2022.Tibial fracture was noted as well.

• Brand Name: OSS MOD PROX TIB 9CM
• 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: 22956154
• Report Number: 0001822565-2025-03241
• Device Sequence Number: 8453290
• Product Code: KRO
• UDI-Device Identifier: 00880304239647
• UDI-Public: (01)00880304239647(17)290207(10)653250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 150443
• Device Lot Number: 653250
• 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: 08/28/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male