MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED LEFT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Radiolucent Lines (4848)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the study patient developed a gradual onset of persistent pain and instability approximately one year post implantation.Radiographic images showed radiolucency surrounding the tibial implant and a triple phase bone scan displayed aseptic loosening.The patient underwent a revision where the femoral and tibial components were found to have minimal ingrowth.All components, except patella, were revised with a revision knee system.No intra-op complications reported.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not retrurned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs.42555805110, lot 64847601, tibial augment cemented half block left lateral size ef 10mm mdr: 0001822565-2023-01318.42555805310, lot 64783331, tibial augment cemented half block left medial size ef 10mm mdr: 0001822565-2023-01319.42560007514, lot 64911499, stem extension tapered cemented 14 mm diameter +75mm mdr: 0001822565-2023-01320.42504606201, lot 64881021, femur cemented standard left size 7 mdr: 0001822565-2023-01321.42556606210, lot 64882685, femoral distal augment cemented size 7, 7+ 10mm mdr: 0001822565-2023-01322.42556606210, lot 64866990, femoral distal augment cemented size 7, 7+ 10mm mdr: 0001822565-2023-01323.42556806205, lot 64859470, femoral posterior augment cemented size 7, 7+ 5mm mdr: 0001822565-2023-01324.42560007514, lot 64911499, stem extension tapered cemented 14 mm diameter +75mm mdr: 0001822565-2023-01325.Additional associated products, 42512600714, lot 64629122, articular surface fixed bearing (cps) left 14 mm unknown patella.110034355, lot k1905z22ba, refobacin bc r 1x40 us cement.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the x-rays to be prior to event/symptoms, radiolucency, no infection, aseptic loosening around the tibial implant, and varus stress possibly causing pain.The complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 FIXED CEMENTED LEFT SIZE E
• 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: 16947971
• Report Number: 0001822565-2023-01317
• Device Sequence Number: 15058707
• Product Code: JWH
• UDI-Device Identifier: 00889024562790
• UDI-Public: (01)00889024562790(17)300912(10)64817993
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 42542007101
• Device Lot Number: 64817993
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 112 KG