MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant ps cem fem ps cem right sz 4.5 (cat# 02-020-11-0345 / serial# (b)(4)).Truliant tib fit tray cem sz 4.5f/3.5t (cat# 02-022-45-4535 / serial# (b)(4)).Advanced patella 35mm 3 peg implant (cat# 200-07-35 / serial# (b)(4)).Collar fixation pin 2pk 40mm, quick release (cat# 201-78-82 / serial# (b)(4)).3" drill bit, mod.Hex 2 pack (cat# 201-78-89 / serial# (b)(4)).3" drill bit, mod.Hex 2 pack (cat# 201-78-89 / serial# (b)(4)).Threaded pin size 2.6 collarless 2pk (cat# 521-78-31 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal team, this male patient complaints of pain and aches in right leg, limping.He said he has been telling his surgeon that for about a year.Patient had x-rays done about a month ago and surgeon said they were fine.Patient is now with recall concerned that surgeon may not have been searching for the right thing and he is going to schedule an appointment with his surgeon for follow-up.Patient also spoke to an attorney.No additional information available.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) as reported by the legal team, this male patient complaints of pain and aches in right leg and limping.He said he has been telling his surgeon that for about a year.Patient had x-rays done about a month ago and surgeon said they were fine.Patient is now with recall and is concerned that surgeon may not have been searching for the right thing and he is going to schedule an appointment with his surgeon for follow-up.Patient also spoke to an attorney.Patient has not been revised.No additional information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• 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: 13969325
• Report Number: 1038671-2022-00339
• Device Sequence Number: 11954007
• Product Code: JWH
• UDI-Device Identifier: 10885862304520
• UDI-Public: 10885862304520
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 4.5 9MM
• Device Catalogue Number: 02-022-35-4509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• 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 THRU 0027-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male