MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM SMOOTH STRAIGHT IM STEM 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); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Radiolucent Lines (4848); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is experiencing continued pain and swelling with femoral component radiolucency and possible loosening approximately five (5) years following left knee arthroplasty.No additional patient consequences were reported.Initial operative notes note no intraoperative complications.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - mak orthopedic salvage system rs distal femoral component left 8.5 catalog #: cp113821 lot #: 230960, orthopedic salvage system rs non-modular tibial plate 67mm catalog #: 161039 lot #: 688410, orthopedic salvage system rs axle catalog #: 161035 lot #: 228810, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: 685750, orthopedic salvage system mak locking pin catalog #: 110008542 lot #: 251420, orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 911970, orthopedic salvage system mak side lock stem screw catalog #: cp113455 lot #: 603040, orthopedic salvage system segmental stacking adapter catalog #: 150483 lot #: 259360, orthopedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 221860, orthopedic salvage system mak bumper catalog #: cp113824 lot #: 151920, orthopedic salvage system polyethylene tibial bearing 12mm catalog #: 150410 lot #: 050980, orthopedic salvage system elliptical diaphyseal segment 3cm catalog #: 150461 lot #: 328080, orthopedic salvage system rs proximal tibial sleeve 3cm catalog #: 161023 lot #: 620850.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 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
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: b4, g3, g6, h2, h3, h6, h11.Radiographic evaluation confirmed a radiolucent line around the femoral component and medical records confirmed the patient was experiencing tenderness with moderate swelling.The device history records were reviewed and no discrepancies were identified.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.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM SMOOTH STRAIGHT IM STEM 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: 22108203
• Report Number: 0001825034-2025-01522
• Device Sequence Number: 8215944
• Product Code: JDI
• UDI-Device Identifier: 00880304033672
• UDI-Public: (01)00880304033672(17)300122(10)137310
• 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
• 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): 10/15/2025

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: CP111649
• Device Lot Number: 137310
• 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: 10/13/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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: Male
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White