MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS CMNTD PROX TIB STEM 11X150; PROSTHESIS, KNEE

Catalog Number	150445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: (b)(6), oss poly tibial bushing, lot: 66090337, (b)(6), oss reinforced yoke, lot: 65889383, (b)(6), oss tibial poly bearing 12mm, lot: 65803951, (b)(6), oss 5cm diaphyseal segment, lot: 080620, (b)(6), oss 9cm prox tib mod cocr, lot: 064520r, (b)(6), oss poly femoral bushings, lot: 65935670, (b)(6), oss poly lock pin, lot: 65974062, (b)(6), oss axle, lot: unknown.H6: suggested component code: mechanical (g04) - stem.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 patient underwent implantation of zimmer biomet devices on an unknown date.Subsequently, the patient has been indicated for a possible revision due to pain in the tibial region.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h6, h10 the following section was corrected: h4 the reported event could not be confirmed.No devices or photographs were received; therefore, the condition of the components is unknown.Review of the device history record identified no deviations or anomalies during manufacturing.X-ray images were received and could not be reviewed by a healthcare professional, as the images were not dated and full construct was not visible.A definitive root cause could not 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 at this time.

• Brand Name: OSS CMNTD PROX TIB STEM 11X150
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22385135
• Report Number: 0001825034-2025-01944
• Device Sequence Number: 8663577
• Product Code: JDI
• UDI-Device Identifier: 00880304239661
• UDI-Public: (01)00880304239661(17)301221(10)179110
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 150445
• Device Lot Number: 179110
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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: Unknown