MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-5009
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.D10.Concomitants - product information: (b)(6) 02-010-03-0250 - logic cr femoral cem, left, sz 5; 3(b)(6) 02-012-45-5040 - lgc tibial fit tray cem sz 5f / 4t; (b)(6) 200-02-32 - three peg patella 32mm.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2016, and then experienced a revision surgical procedure on (b)(6) 2020, approximately 4 years, 6 months after initial implant.Revision operative report of (b)(6) 2020 - postoperative diagnosis: loose left total knee replacement.The polyethylene was removed, the femoral component was noted to be grossly loose.It¿s appearance looked good, however, it was noted to be loose.The patient tolerated the procedure well.The devices were not returned, there are no images provided.There is no other information available.
Additional Manufacturer Narrative
1038671-2024-03335 h6: corrected health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: the revision reported may have been the result of aseptic loosening, as stated in the operative notes.The aseptic (non-infected) loosening may have been the result of insufficient bonds between the implants and the bones.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 5, 9MM
• 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 FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18904645
• Report Number: 1038671-2024-00507
• Device Sequence Number: 7919924
• Product Code: JWH
• UDI-Device Identifier: 10885862174611
• UDI-Public: 10885862174611
• Combination Product (Y/N): N
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2020
• Device Catalogue Number: 02-012-49-5009
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Unknown