MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW 11MM X 150MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834); Radiolucent Lines (4848); Aseptic loosening (4883); Periprosthetic fracture (4902)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - mak oss rs segmental elliptical femoral component 7cm right catalog #: cp113814 lot #: 236800, oss rs non-modular tibial plate long 71mm catalog #: 161041 lot #: 748420, mak oss side lock stem screw catalog #: cp113455 lot #: 007740, oss reinforced yoke catalog #: 150493 lot #: 901630, oss poly tibial bushing catalog #: 150476 lot #: 923020, oss mak lock pin catalog #: 110008542 lot #: 250450, oss polyethylene tibial bearing 16mm catalog #: 150412 lot #: 153950, mak oss bumper catalog #: cp113824 lot #: 976830, oss rs axle catalog #: 161035 lot #: 902650, oss rs polyethylene femoral bushings set of 2 catalog #: 161034 lot #: 919000.H6 - component code - proposed code is mechanical (g04) stem.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.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 the patient underwent a right knee arthroplasty revision to address pain, femoral component loosening and a right femoral stress fracture approximately three (3) years post-operatively.All components were revised and replaced.Initial operative notes noted no intraoperative complications.Revision operative notes noted gross motion of the femoral implant within the bone, indicative of fibrous union.Assessment of femoral and tibial bone defects were additionally noted.No implants were placed without complication.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Medical records provided confirmed the reported event.The device history records were reviewed and no discrepancies were identified.The implants were noted to have been used with competitor implants.The instructions for use for the implants used note not to not use components of zimmer biomet with components of any other system or manufacturer unless authorized by zimmer biomet, however, a definitive root cause could not be determined with the information provided.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 further event information available at the time of this report.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW 11MM X 150MM
• 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: 22096957
• Report Number: 0001825034-2025-01507
• Device Sequence Number: 6926432
• Product Code: JDI
• UDI-Device Identifier: 00880304033702
• UDI-Public: (01)00880304033702(17)290218(10)733890
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP111652
• Device Lot Number: 733890
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White