MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT CR POR FEM CR POR LEFT SZ 3

Model Number	02-020-14-0230
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, after the left tka, in the post op x-rays, porous beads dislodged from implant and are seen on x-ray following the case.Patient was last known to be in stable condition following the event device not returning as it was implanted.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the event was most likely the result of a combination of the patient¿s very hard bone quality in addition to the component being impacted onto the prepared bone multiple times.However, neither the failure nor most likely cause can be confirmed as the device was not returned for evaluation due to being implanted and the fragments were not recovered.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT CR POR FEM CR POR LEFT SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10837203
• Report Number: 1038671-2020-00609
• Device Sequence Number: 3349065
• Product Code: JWH
• UDI-Device Identifier: 10885862315007
• UDI-Public: 10885862315007
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02-020-14-0230
• Device Catalogue Number: 02-020-14-0230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other