MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6.5 years post initial tka, the female patient femur had an increased posterior dwell point- whether the sloped poly or a compromised pcl was the root cause is unclear.This likely led to the early delamination of the posterolateral aspect of the poly bearing.There was also significant osteolysis under the posterior condyles- although the femur wasn¿t grossly loose.Patient was revised to a competitor's devices.Per sales rep "we have seen a similar trend in our complaints/retrieval database of aged/sloped cr poly bearings.".
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, right, sz 3 (cat# 02-010-03-0330 / serial# (b)(4).Lgc tibial fit tray cem sz 3f / 3t (cat# 02-012-45-3030 / serial# (b)(4).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(4).Collar fixation pin 2pk 40mm, quick release (cat# 201-78-82 / serial# (b)(4).Stryker kms1312.M62 90x13x1.19mm (cat# 203-96-50 / serial# (b)(4).Threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information: please disregard this report as it was submitted in error.Event will be reported under report 1038671-2022-01539.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15834337
• Report Number: 1038671-2022-01491
• Device Sequence Number: 5126693
• Product Code: JWH
• UDI-Device Identifier: 10885862174383
• UDI-Public: 10885862174383
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 11/05/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 3, 9MM
• Device Catalogue Number: 02-012-48-3009
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female