MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; PS TIBIAL INSERTS SZ 2, 15MM

Model Number	204-22-15
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.
Event or Problem Description
It was reported that a right knee was implanted in 2014.A revision was scheduled to take place on (b)(6) 2019.Upon opening the knee, the surgeon noticed that the post of the insert was broken off and free floating in the knee.Upon further exposure, he recognized that the poly was severely delaminated on the lateral side, anterior aspect, post, and partially underneath the poly.The surgeon then washed out the patient¿s knee, and exchanged the poly for an size 2, 22mm poly, in exchange for the 15mm that was in there previously.The surgeon is completing further observation prior to sending device back.To this manufacturer.Patient is (b)(6) and roughly around (b)(6).No relevant history is known.Initial implant in 2014.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported may have been the result of either excessive flexion between the femoral component and the tibial spine or axial rotation mismatch between the femoral component and the tibial components; likely leading to offset/asymmetrical contact between the femoral cam and the ps tibial insert spine, which may have precipitated the fracture of the tibial spine.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EXACTECH
• Common Device Name: PS TIBIAL INSERTS SZ 2, 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9353336
• Report Number: 1038671-2019-00576
• Device Sequence Number: 1954099
• Product Code: JWH
• UDI-Device Identifier: 10885862048257
• UDI-Public: 10885862048257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 204-22-15
• Device Catalogue Number: 204-22-15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84