MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 3, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 12.5 years post initial left tka, the 79 y/o female patient was revised due to osteolysis as a result of poly wear.The patient was revised to a 35mm patella.The tibial insert was revised to a sz 3 femoral component and a sz3, 11mm tibial insert.There was no breakage of device.There was a more than 45 minutes surgical delayed due to surgeon performed replaced the opti fem with a cc logic, stem + post 5mm wedges.Patient was last known to be in stable condition following the event.Imagers and x-rays received.The devices are not available for evaluation due to the implants were discarded at hospital.
Additional Manufacturer Narrative
Section d10: concomitant products.Optetrak 3 peg patella cemented (cat# 200-02-32).Optetrak asymmetric femoral posterior stabilized, cemented sz 3, left (cat# 234-02-03 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g1, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported may have been due to orientation of the components, patient related conditions, instability, or any combination of these possibilities, which led to prosthesis wear and osteolysis.Additionally, the components were implanted for over 12 years which likely contributed to the reported wear.However, this cannot be confirmed because the component was not returned for evaluation.The most probable root cause for 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.Furthermore, the most probable root cause for the event ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10: concomitant products: optetrak 3 peg patella cemented (cat# 200-02-32).Optetrak asymmetric femoral posterior stabilized, cemented sz 3, left (cat# 234-02-03; serial# (b)(6)).The revision reported may have been due to orientation of the components, patient related conditions, instability, or any combination of these possibilities, which led to prosthesis wear and osteolysis.Additionally, the components were implanted for over 12 years which likely contributed to the reported wear.However, this cannot be confirmed because the component was not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 3, 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 18832835
• Report Number: 1038671-2024-00385
• Device Sequence Number: 7485706
• Product Code: JWH
• UDI-Device Identifier: 10885862048301
• UDI-Public: 10885862048301
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2017
• Device Model Number: PS TIBIAL INSERTS SZ 3, 9MM
• Device Catalogue Number: 204-23-09
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/13/2024; 12/04/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/30/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 80 KG