MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPAEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 79MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address post-operative instability and bone preservation.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - orthopaedic salvage system poly lock pin catalog #: 150478 lot #: 395950, orthopaedic salvage system 4cm diaphyseal segment catalog #: 150482 lot #: 640430, orthopaedic salvage system cemented im stem 15mm x 150mm catalog #: 150369 lot #: 055900, orthopaedic salvage system 7cm segmental femoral component right catalog #: 150354 lot #: 782310, series a 3 peg patella thin 37mm x 8.6mm catalog #: 184788 lot #: 277320, orthopaedic salvage system polyethylene tibial bearing 16mm catalog #: 150412 lot #: 622440, orthopaedic salvage system reinforced yoke catalog #: 150493 lot #: 293580, orthopaedic salvage system polyethylene femoral bushings catalog #: 150477 lot #: 096430, orthopaedic salvage system axle catalog #: 150480 lot #: 942420, orthopaedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 540910.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices were discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-01892, 0001825034-2023-01896, 0001825034-2023-01897, 0001825034-2023-01898, 0001825034-2023-01900, 0001825034-2023-01901, 0001825034-2023-01903, 0001825034-2023-01904, 0001825034-2023-01905, 0001825034-2023-01906.H3 other text : investigation incomplete.
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 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: ORTHOPAEDIC SALVAGE SYSTEM MODULAR TIBIAL BASEPLATE 79MM
• 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: 17552863
• Report Number: 0001825034-2023-01899
• Device Sequence Number: 20567870
• Product Code: JDI
• UDI-Device Identifier: 00880304239456
• UDI-Public: (01)00880304239456(17)241109(10)689560
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K002757
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Expiration Date: 11/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 150424
• Device Lot Number: 689560
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male