MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPAEDIC SALVAGE SYSTEM COMPRESS SMALL SHORT SPINDLE WITH PINS 600LBF; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Joint Contracture (4528); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopaedic salvage system compress short anchor plug 10mm catalog #: 178552 lot #: 148690, orthopedic salvage system compress nut catalog #: 178512 lot #: 269230, orthopaedic salvage system compress transverse pin 6pk 24mm catalog #: 178525 lot #: 173280, orthopaedic salvage system compress short anchor plug 10mm catalog #: 178552 lot #: 148700, orthopaedic salvage system compress xs short spindle with pins 400lbf catalog #: 178362 lot #: 204810, orthopaedic salvage system compress transverse pin 6pk 24mm catalog #: 178525 lot #: 197590, orthopaedic salvage system compress nut catalog #: 178512 lot #: 269230, orthopaedic salvage system compress 5cm taper adaptor with screw catalog #: 178711 lot #: 080030, orthopaedic salvage system rs 9cm proximal modular tibia catalog #: cp113461 lot #: 357890, orthopedic salvage system rs distal femur right 15cm catalog #: cp114842 lot #: 459150, orthopaedic salvage system reinforced yoke catalog #: 150493 lot #: 896980, orthopaedic salvage system rs axle catalog #: 161035 lot #: 514100, orthopaedic salvage system poly tibial bushing catalog #: 150476 lot #: 65718067, orthopaedic salvage system poly locking pin catalog #: 150478 lot #: 432220 e1 - the surgeon's name is dr.(b)(6).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
It was reported that the patient is being considered for a right knee arthroplasty revision due to unknown reasons.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, b4, b5, e1, e2, e3, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that the patient is being considered for a right knee arthroplasty revision to address flexion contracture and stiffness approximately twenty-two (22) months following knee arthroplasty.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ORTHOPAEDIC SALVAGE SYSTEM COMPRESS SMALL SHORT SPINDLE WITH PINS 600LBF
• 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: 21036165
• Report Number: 0001825034-2024-03075
• Device Sequence Number: 12676638
• Product Code: KWA
• UDI-Device Identifier: 00880304509047
• UDI-Public: (01)00880304509047(17)281203(10)151440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178366
• Device Lot Number: 151440
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 02/27/2025; 06/04/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/19/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• 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: Female