MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a right knee revision approximately thirteen months post-implantation due to pain and loosening of the tibial tray.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: femur cemented cruciate retaining (cr) standard right size 11 catalog#: 42502607002 lot#: 64355854.Articular surface medial congruent (mc) right 10 mm height catalog#: 42522100910 lot#: 64798941.Unknown bone cement catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00014, 3007963827-2023-00031, and 0001822565 -2023-00464.D10 medical devices: femur cemented cruciate retaining (cr) standard right size 11, catalog#: 42502607002, lot#: 64355854.Articular surface medial congruent (mc) right 10 mm height, catalog#: 42522100910, lot#: 64798941.Unknown bone cement catalog#: ni, lot#: ni.Unknown tibial stem extension catalog#: ni, lot#: ni.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately thirteen months post-implantation due to pain and loosening of the tibial tray.During the revision, bone loss was noted around the femoral and the tibial tray and stem.
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.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available medical records identified the following: radiolucent lines along the tibial component, aseptic loosening of the tibial component, tibial and femoral bone loss and instability, and excessive scar tissue surrounding patella.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE G
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16311184
• Report Number: 3007963827-2023-00014
• Device Sequence Number: 17879270
• Product Code: JWH
• UDI-Device Identifier: 00889024471108
• UDI-Public: (01)00889024471108(17)310224(10)64965345
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2023

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 Model Number: N/A
• Device Catalogue Number: 42532007902
• Device Lot Number: 64965345
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 01/30/2023; 04/07/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 02/22/2023; 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White