MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-3513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"legal case ¿ usa (mdl no.3044) patient id: (b)(6) + left knee (b)(4) rk rev is associated with this case" "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 02-012-49-3513 - logic cr tib insert slope ++, sz 3.5, 13 mm serial:(b)(6).510k: k111400 udi: (b)(4).Product code: jwh x-ray: no operative notes: no.Concomitant devices: (5241951) 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t, (5343760) 200-02-32 - three peg patella 32mm, (5361734) 02-010-03-0235 - logic cr femoral cem, left, sz 3.5".
Additional Manufacturer Narrative
D10 concomitant devices (5241951) 02-012-45-3545 - lgc tibial fit tray cem sz 3.5f / 4.5t ; (5343760) 200-02-32 - three peg patella 32mm; (5361734) 02-010-03-0235 - logic cr femoral cem, left, sz 3.5.The product associated with the reported event is within the scope of recall z-0021-2022; 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
The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.
Additional Manufacturer Narrative
H6: corrected health effect impact code, type of investigation.Manufacturer narrative updated: the reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 13 MM
• 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: 19770619
• Report Number: 1038671-2024-02403
• Device Sequence Number: 20983644
• Product Code: JWH
• UDI-Device Identifier: 10885862159335
• UDI-Public: 10885862159335
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2024
• Device Catalogue Number: 02-012-49-3513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 11/06/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 11/08/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2016
• 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.
• Patient Sex: Male