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

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient a left knee revision approximately two and a half years post-implantation due to pain and tibial subsidence.During removal of the tibial tray, it was noted that the cement remained attached to the medial side of the tibia (which had subsided) and came detached from the lateral side.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10 medical products: biomet bc r 1x40 us catalog#: 110035368.Lot#: 005eae2047.Femur cemented cruciate retaining (cr) standard left size 10 catalog#: 42502606801.Lot#: 64808009.Articular surface medial congruent (mc) left 14 mm height catalog#: 42512100814.Lot#: 64666580.All poly patella cemented 32 mm diameter catalog#: 42540000032.Lot#: 64825834.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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.The reported event was confirmed via medical records.No product or pictures were provided.The medical records and x-rays provided were reviewed by a healthcare professional and identified reported knee pain, negative for infection, with the tibia looking to have subsided, along with grossly loose.The tibial component was removed easily and the surgeon noted a large defect in the medial tibial plateau, along with scar tissue.Bone quality was also noted to be osteopenic.The femoral component was downsized, patella remained implanted.Tibial loosening and subsidence resulted in malalignment.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient a left knee revision approximately two and a half years post-implantation due to pain and tibial subsidence.Scar tissue was noted at the revision.During removal of the tibial tray, it was noted that the cement remained attached to the medial side of the tibia (which had subsided) and came detached from the lateral side.No additional patient consequences were reported.
Event or Problem Description
No additional information.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE F
• 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: 17741195
• Report Number: 3007963827-2023-00245
• Device Sequence Number: 20348631
• Product Code: JWH
• UDI-Device Identifier: 00889024471078
• UDI-Public: (01)00889024471078(17)300531(10)64682181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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): 01/02/2024

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: 42532007501
• Device Lot Number: 64682181
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 10/09/2023; 12/20/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/06/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male