MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic femoral ps cem left sz 1.5 (cat# 02-010-01-0215 / serial# (b)(4)).Stem extension 25 lx12 mm (cat# 204-32-02 / serial# (b)(4)).Three peg patella 32mm (cat# 200-02-32 / serial# (b)(4)).Lgc tibial fit tray cem sz 1.5f / 1.5t (cat# 02-012-45-1515 / serial# (b)(4)).Holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4)).Threaded pin size 3.0 collarless (cat# 521-78-32 / 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)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 1.5 yr post initial l tka, this (b)(6) y/o female patient had a left knee revision due to instability.Insert was changed from 11mm to a 15mm.Patient was last known to be in stable condition following the event.The device will not be returned for analysis as the device was disposed by hospital.Only the insert was revised per the experience report.
Additional Manufacturer Narrative
After further review of additional information received.(h3) as reported, approximately 1.5 yr post initial l tka, this 66 y/o female patient had a left knee revision due to instability.Insert was changed from 11mm to a 15mm.Patient was last known to be in stable condition following the event.The device will not be returned for analysis as the device was disposed by hospital.Only the insert was revised per the experience report.Upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3: the reason for the revision reported was likely the result of instability and/or possible prosthesis wear.However, the instability and prosthesis wear could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.The reason for filing a claim at this time may be due to inclusion of the polyethylene in the packaging recall.H6: annex e codes, annex a codes, component code, investigation conclusion code.The following sections were corrected: h3: investigation conclusion.H6: annex e code - 1924 no longer applies, annex a code - 2993 no longer applies, investigation code 50 no longer applies.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.D10 concomitant medical products: -logic femoral ps cem left sz 1.5 (cat# 02-010-01-0215 / serial# (b)(6)).-stem extension 25 lx12 mm (cat# 204-32-02 / serial# (b)(6)).-three peg patella 32mm (cat# 200-02-32 / serial# (b)(6)).-lgc tibial fit tray cem sz 1.5f / 1.5t (cat# 02-012-45-1515 / serial# (b)(6)).-holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(6)).-threaded pin size 3.0 collarless (cat# 521-78-32 / serial# (b)(6)).-3 trocar, mod.Hex 2pk (cat# 201-78-81 / serial# (b)(6)).-threaded pin size 2.3 collared (cat# 521-78-23 / serial# (b)(6)).-tibial stem ext.Screw (cat# 204-70-00/ serial# (b)(6)).The reason for the revision reported was likely the result of instability and/or possible prosthesis wear.However, the instability and prosthesis wear could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.The reason for filing a claim at this time may be due to inclusion of the polyethylene in the packaging recall.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 1.5, 11MM
• 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: 11806223
• Report Number: 1038671-2021-00224
• Device Sequence Number: 3481557
• Product Code: JWH
• UDI-Device Identifier: 10885862173447
• UDI-Public: 10885862173447
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02-012-44-1511
• 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: 04/25/2021
• Supplement Date Received by Manufacturer: 06/02/2021; 12/29/2023; 01/06/2025
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/09/2021; 01/06/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2019
• 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: SEE H11
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female