MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2021

Event Type  Injury  

Event Description

As reported, a (b)(6) female patient underwent index arthroplasty in (b)(6) 2019.Her poly was manufactured in june 2014.Patient did well for 6 months, then started to develop persistent, large effusions.Infection work up negative.X-rays show classic pattern of medial tibial plateau radiolucency and radiolucency under femoral flange.She underwent revision by another practitioner recently.Patient was told she had extensive delamination of the poly with extensive bone loss.No additional information available.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received the following sections d1, d4, d6a, d10, g3, g4, g6, h2, h3, h4 and h6 have been updated accordingly.Section d10: concomitants products: - logic femoral ps cem right sz 4 (cat# 02-010-01-0340 / serial# (b)(6)).- logic tibia implant psc insert, sz 4, 9mm (cat# 02-012-44-4009 / serial# (b)(6)).- lgc tibial fit tray cem sz 4f / 4t (cat# 02-012-45-4040 / serial# (b)(6)).- three peg patella 35mm (cat# 200-02-35 / serial# (b)(6)).- saw blade new stryk (.050) (cat# 203-96-01 - (11-2222) / serial# (b)(6)).- saw blade new stryker (.050) (cat# 203-96-03 - (11-2216) / serial# (b)(^)).(h3) the revision reported was likely the result of radiolucencies observed on pre-revision x-rays, which may indicate loosening at the bone/implant interface.The ¿extensive delamination¿ reported cannot be confirmed from the information provided but may have been the result of third body wear.However, this cannot be confirmed because the devices were not returned to exactech for evaluation.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.Furthermore, the most probable root cause associated with the reported event of "loosening¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• Type of Device: 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: 13122642
• MDR Text Key: 288114508
• Report Number: 1038671-2021-00741
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862173638
• UDI-Public: 10885862173638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
• Device Catalogue Number: 02-012-44-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female