MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 3.5f / 3.5t (cat# 02-012-45-3535 / serial# (b)(4)).Three peg patella 38mm (cat# 200-02-38 / serial# (b)(4)).Logic cr femoral por, left, sz 3.5 (cat# 02-010-04-0235 / serial# (b)(4)).Gps implant kit v2 (cat# a10012 / serial# (b)(4)).Holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4)).Threaded pin size 2.3 collared (cat# 521-78-23 / serial# (b)(4)).3 trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(4)).Threaded pin size 2.3 collared (cat# 521-78-23 / serial# (b)(4)).Threaded pin size 3.0 collarless (cat# 521-78-32 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, a male, (b)(6), weight is unknown, initial implant of (b)(6) 2019.Primary left knee case was performed (b)(6) 2019, pcl ruptured as per x-ray.He had l3/4 spine issues and weak quads because of back.Had spine operation few weeks ago.Poly wear noted in provided x-rays.Patient was last known to be in stable condition following the event.Device will return.
Additional Manufacturer Narrative
(h3) the patient conditions reported appear to have led to excessive tension on the pcl, joint instability, and subsequent wear of the tibial insert, which necessitated the revision.Improper tensioning of the pcl has been found to contribute to excessive rollback of the femoral component, leading to higher shear and compressive forces on the polyethylene.The most probable root cause associated with the reported event of "prosthesis wear" is associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.

• Brand Name: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
• 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: 12569147
• Report Number: 1038671-2021-00508
• Device Sequence Number: 11790413
• Product Code: JWH
• UDI-Device Identifier: 10885862159328
• UDI-Public: 10885862159328
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 05/06/2022
• Device Model Number: LOGIC CR TIB INSERT SLOPE ++, SZ 3.5, 11 MM
• Device Catalogue Number: 02-012-49-3511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male