MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 13MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: fluted stem extension 120l x 14 mm (cat# 204-34-12 / serial# (b)(4)).Tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4)).Logic pts, size 4, 8mm (cat# 02-012-42-4008 / serial# (b)(4)).Lgc tibial fit tray cem sz 4f / 3t (cat# 02-012-45-4030 / serial3 (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately fifteen years post initial left tka, the (b)(6) male patient had a full revision going to a constrained knee.Patient's revision was due to instability of femoral component.There was poly wear and metallosis due to the 8mm tibial spacer and osteolysis was also present.Patient was revised to a size 4 left constrained femur with splined stems in the femur and tibia as well as metaphyseal cones and a 25 mm constrained liner.There was no device breakage or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays and photos received.The devices will be returned.As of note: "patient was revised in 2014 with loosening of the tibia and the size 4/13mm posters stabilized tibial insert reference number 204¿24¿13 with serial number (b)(4).Is a non-conformed insert that it is on the list of polys".
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of patient-related conditions including the fall reported, malalignment, instability, third body wear, or any combination of these possibilities, which led to prosthesis wear, osteolysis, and metallosis.Additionally, a contributing factor to the 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: PS TIBIAL INSERTS SZ 4, 13MM
• 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: 14357051
• Report Number: 1038671-2022-00545
• Device Sequence Number: 4077379
• Product Code: JWH
• UDI-Device Identifier: 10885862048400
• UDI-Public: 10885862048400
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 02/14/2023

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: 04/21/2016
• Device Model Number: PS TIBIAL INSERTS SZ 4, 13MM
• Device Catalogue Number: 204-24-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2008
• 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-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male