MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(4)).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)).Logic cr femoral cem, left, sz 4 (cat# 02-010-03-0240 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported approximately 5 yrs postop the ltka on this female patient the surgeon completed a poly exchange on this same patient.The poly that was removed was heavily worn and damaged, and the surgeon asked that it be sent back to the manufacturer for further examination.The surgeon swapped this implant for a crc poly during the revision.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
The revision reported was likely the result of a combination of axial rotation mismatch of the femoral component relative to the tibial insert and overall posterior slope of the tibial insert, which allowed for excessive posterior contact, especially medially, and led to severe wear of the polyethylene.Additionally, a contributing factor to the severe wear and delamination may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The most probable root cause associated with the reported event of "prosthesis wear" is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 4, 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: 12381201
• Report Number: 1038671-2021-00421
• Device Sequence Number: 19937917
• Product Code: JWH
• UDI-Device Identifier: 10885862174529
• UDI-Public: 10885862174529
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 11/09/2019
• Device Model Number: LOGIC CR TIB INSERT SLOPE++, SZ 4, 11MM
• Device Catalogue Number: 02-012-49-4011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 08/28/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2011
• 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 Sex: Female