MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS CEM RIGHT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-01-0320
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
**28-aug-2024 additional information** legal case ¿ (b)(4).Patient id:(b)(6), (b)(4), left knee is associated with this case.It is reported via legal documentation (short form complaint attached) that plaintiff underwent right knee revision (b)(6) 2023.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.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.The serial number (b)(6) is confirmed to be a part of recall number: z-0021-2022 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t serial: (b)(6) 510k: k101981 udi: (b)(4).Product code: jwh x-ray: no operative notes: no concomitant devices: (2729255) 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t (2861615) 02-010-01-0320 - logic femoral ps cem right sz 2 (2955695) 200-02-32 - three peg patella 32mm **original summary** legal case usa ¿ loretta revis rk rev as reported via legal documentation the patient had a right knee replacement on 3 mar 2014.Approximately 8 years and 11 months after the initial procedure the patient had a right knee revision on 1 feb 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on 1 feb 2023 diagnosis: failed right total knee due to premature poly wear and failed femoral component due to osteolysis findings: there was found to be a clean wound with clear synovial joint fluid.There was found to be severe wear of the polyethylene of the tibial component.There was a grossly loose femoral component that was loose from the cement mantle.There was no cement adherent to the back side of the femoral component.The tibial component was found to be well fixed to bone and the patellar component was found to be well fixed.Ebi initial surgery attached.Historical record and smartsolve searched for sn/patient name with no results.As directed by qa management: this legal complaint for polyethylene issues occurred in the us.The event did not occur in, nor is it reportable for australia, brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.2841515 02-012-35-3011 - logic tibia ps mod insrt sz 3 11mm ***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k033883 recall: z-0021-2022 concomitants: 2837911 02-010-01-0230 - logic femoral ps cem left sz 3 2833339 02-012-45-3020 - lgc tibial fit tray cem sz 3f / 2t 2858564 200-02-32 - three peg patella 32mm.
Additional Manufacturer Narrative
D10 concomitant devices (b)(6) 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t ((b)(6) 200-02-32 - three peg patella 32mm (b)(6) 02-012-35-2011 - logic tibia ps mod insrt sz 2 11mm 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.
Additional Manufacturer Narrative
H6: added the following: health effect - medical device problem codes.

• Brand Name: LOGIC FEMORAL PS CEM RIGHT SZ 2
• 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: 20133925
• Report Number: 1038671-2024-03251
• Device Sequence Number: 15278054
• Product Code: JWH
• UDI-Device Identifier: 10885862001214
• UDI-Public: 10885862001214
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 10/25/2024

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: 11/05/2018
• Device Catalogue Number: 02-010-01-0320
• 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: 08/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female