MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 11, 11+ 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee surgery.Subsequently, the patient had swelling in the left knee resulting in a left knee aspiration approximately 2.5 years later.No further complications or results were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 42504607001 - femur cemented standard left size 11 - 64655857.42560117518 - stem extension straight splined uncemented 18 mm diameter +175 mm length - 64716473.42542007901 - tibia fixed cemented left size g stem extension use required - 64679178.42512801012 - articular surface fixed bearing constrained condylar knee (cck) left 12 mm height use with tibia sizes g, h / revision femur sizes 11, 11+, 13 with lo - 64341097 - 42560317514 - stem extension 3mm offset splined uncemented 14 mm diameter +175 mm length - 64739783.42545000513 - tibial central cone size large - 64800272.Unknown - unknown patella - unknown.Unknown - unknown palacos cement - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03501, 0001822565-2022-03503, 0001822565-2022-03507, 0001822565-2022-03509, 0001822565-2022-03510, 3005751028-2022-00022, 0001822565-2022-03511.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient works as a structural maintenance journeyman, pain for over 1 year, effusion resulting in aspiration relieves pain, no synovial fluid culture.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was further reported that the patient continued to present with recurrent pain and swelling in the knee as well as instability and laxity.The patient was then revised and during the revision, the femoral component was found grossly loose and was revised without complications.The tibial and patellar components were well-fixed and remained intact.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 following sections were updated: revision operative notes confirm that patient was revised due to loosening, pain, effusions and laxity.Femoral component was found to be loose and was extracted without difficulty.Total of nine pre-operative and post-operative images were reviewed and not submitted to mmi as there is sufficient documentation within the medical records and submission would not enhance the investigation.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: FEMORAL POSTERIOR AUGMENT CEMENTED SIZE 11, 11+ 5 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15988254
• Report Number: 0001822565-2022-03502
• Device Sequence Number: 5961871
• Product Code: JWH
• UDI-Device Identifier: 00889024556942
• UDI-Public: (01)00889024556942(17)300914(10)64804890
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 42556807005
• Device Lot Number: 64804890
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 03/06/2023; 04/26/2024; 10/29/2024
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/09/2023; 05/09/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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: Required Intervention; Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White