MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case charles nelson rk rev as reported via legal documentation, this patient had a right knee revision (b)(6) 2015.The patient presents with a painful and unstable right knee replacement.The patient was noted to have aseptic loosening of the femoral component and marked osteolysis.The patient has failed conservative management including activity modification and anti-inflammatory medications.They had right knee revision (b)(6) 2023, approximately 7 years, 5 months after their initial replacement.Pre & post op diagnosis for revision: right knee failed total knee replacement, right knee aseptic loosening femoral component, right knee osteolysis severe.From description of procedure: there was very extensive synovitis and a very thorough synovectomy of the joint was performed.The polyethylene liner was removed.There was noted to be wear of the liner with delamination.Next the femoral component was noted to be loose and it was removed.There was significant fibrous tissue beneath it with marked osteolysis.There was no evidence of infection grossly although multiple specimens were sent to pathology.The patient was transferred to the recovery room in stable condition.No device return anticipated due to this being a legal case.Historical record & smartsolve searched for sn/patient name with no results.Unable to locate ebi initial surgery, as this is an hss case.No additional information.3952113 02-012-44-4013 logic tibia implant psc insert, sz 4, 13mm serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k110547.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, patella loosening and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 16771103
• Report Number: 1038671-2023-00754
• Device Sequence Number: 6386556
• Product Code: JWH
• UDI-Device Identifier: 10885862173652
• UDI-Public: 10885862173652
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 04/30/2023
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM
• Device Catalogue Number: 02-012-44-4013
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male