MAUDE Adverse Event Report: EXACTECH, INC. LOGIC PSC TIB INS SZ 5 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-44-5017
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 16022301 660-01-10 - ossilix / form 10cc calcium phosphate.4124267 02-012-60-2012 - tru stem ext 20mm x 120mm.4231073 02-010-06-0250 - tru cc femoral size 5 left.4243473 208-05-05 - cc distal fem augment sz 5, 5mm.4417040 02-010-06-0551 - tru post.Aug.Size 5, 5mm.4417041 02-010-06-0551 - tru post.Aug.Size 5, 5mm.4845810 02-012-61-4000 - tru offset stem ext coupler, 4mm.4872346 208-05-05 - cc distal fem augment sz 5, 5mm.4901712 200-02-38 - three peg patella 38mm.4954951 02-012-60-1212 - tru stem ext 12mm x 120mm.5022823 204-70-00 - tibial stem ext.Screw.5118737 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.
Event or Problem Description
As reported via legal documentation, this patient had left knee revision (b)(6)2017.They had left knee revision on (b)(6)2023, approximately 5 years 2 months after their initial procedure.There was found to be a loose tibial component with a completely loose tibial stem.There was found to be a moderate amount of polyethylene wear within the tibial polyethylene.There was evidence of polyethylene wear and synovial encapsulation.There was a heterotopic bone formed around the patella with a loose patellar component.The patient also had developed a pretibial ganglion cyst due to the loose tibial component rubbing up against the anterior cortex of his mid left tibia.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.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-04460, 1038671-2024-04459.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: LOGIC PSC TIB INS SZ 5 17MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXATECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17129033
• Report Number: 1038671-2023-01346
• Device Sequence Number: 17742418
• Product Code: JWH
• UDI-Device Identifier: 10885862248183
• UDI-Public: 10885862248183
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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?: No
• Device Expiration Date: 01/30/2022
• Device Model Number: 02-012-44-5017
• Device Catalogue Number: 02-012-44-5017
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• 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: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male