MAUDE Adverse Event Report: EXACTECH, INC. TRU CC FEMORAL SIZE 4 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-06-0240
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (mdl no.(b)(4)).Patient id: (b)(6) + left knee.(b)(6) 2024: attached legal short form.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.(b)(4), and pending in the (b)(6).Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.As reported by the legal team, approximately 4.1 years post initial left tka, the 59 year old male patient had a revision due to premature poly wear and poly recall with osteolysis and loosening of the femoral and tibial components.During revision surgery, it was found to be a clean wound with clear synovial joint fluid.There were found to be grossly loose femoral and tibial components that were easily removed with a bone tamp.There was also found to be a well-fixed patellar button.There was a moderate amount of polyethylene wear, both visibly and palpable on the tibial polyethylene component.There was encapsulated polyethylene debris within the synovium and a complete synovectomy was performed.Patient was revised to competitors devices.The patient was awakened and transferred to recovery in stable condition.The devices are not available for evaluation.Concomitant products: logic fit/rbk augment 1/2 block rl/lm sz5 10mm (cat# 02-012-50-5014 / serial# (b)(6)); tru fluted stm ext 18mm x 80mm blast (cat# 02-012-64-1880 / serial# (b)(6)); logic cc femoral size 4, left (cat# 02-010-06-0240 / serial# (b)(6)); three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)); tru fluted stm ext 16mm x 80mm blast (cat# 02-012-64-1680 / serial# (b)(6)); truliant tib fit tray cem sz 4f / 5t (cat# 02-022-45-4050 / serial# (b)(6)); tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6)).Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k171045.
Additional Manufacturer Narrative
D10 concomitant products: logic fit/rbk augment 1/2 block rl/lm sz5 10mm (cat# 02-012-50-5014 / serial# (b)(6)); tru fluted stm ext 18mm x 80mm blast (cat# 02-012-64-1880 / serial# (b)(6)); logic cc femoral size 4, left (cat# 02-010-06-0240 / serial# (b)(6)); three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)); tru fluted stm ext 16mm x 80mm blast (cat# 02-012-64-1680 / serial# (b)(6)); truliant tib fit tray cem sz 4f / 5t (cat# 02-022-45-4050 / serial# (b)(6)); tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6)).The product associated with the reported event is within the scope of recall however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.

• Brand Name: TRU CC FEMORAL SIZE 4 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville 32653 ; 3523771140
• MDR Report Key: 20494596
• Report Number: 1038671-2024-04044
• Device Sequence Number: 3519872
• Product Code: JWH
• UDI-Device Identifier: 10885862612410
• UDI-Public: 10885862612410
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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 Expiration Date: 09/11/2023
• Device Catalogue Number: 02-010-06-0240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 09/11/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male