MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-2510
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a right total knee arthroplasty on (b)(6) 2018.The patient has not been surgically revised.There is no other patient or medical information provided.There are no images of the device provided.No additional information is available.The patient had simultaneous bilateral knee replacements, the searchable information does not clarify the device that was actually implanted.02-022-35-2510 is a reasonable selection of device/z-0023-2022 [out of 3 devices 2 are 10mm inserts].
Additional Manufacturer Narrative
H10.Implanted device was not identified: m001394 02-022-35-2509 - truliant tib imp ps insert sz 2.5 9mm 5070387 02-022-35-2510 - truliant tib imp ps insert sz 2.5 10mm m005691 02-022-35-2510 - truliant tib imp ps insert sz 2.5 10mm it is not possible to determine the insert - the invoice number is the same and the left and right femoral component are the same size - so we cannot determine the insert becasue the are the same size concomitant: 5064530 02-020-11-0225 - truliant ps cem fem ps cem left sz 2.5 5487021 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5 5371638 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t 5509010 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t 5394455 200-07-32 - advanced patella 32mm 3 peg implant 5417570 200-07-32 - advanced patella 32mm 3 peg implant 5020076 521-78-23 - threaded pin size 2.3 collared 2pk these devices are used in treatment and not for diagnosis.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The following sections were corrected: h6.The reason for the reported event in (b)(4) cannot be confirmed from the information provided but may be due to prosthesis wear and instability and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18967638
• Report Number: 1038671-2024-00655
• Device Sequence Number: 6299152
• Product Code: JWH
• UDI-Device Identifier: 10885862304179
• UDI-Public: 10885862304179
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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 Catalogue Number: 02-022-35-2510
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown