MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 2, 13MM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patella cemented (cat# 200-02-06 / serial# (b)(4)).Optetrak tivial tray (cat# 204-04-22 / serial# (b)(4)).Optetrak asymmetric femoral posterior stabilized cemented size 2 left (cat# 234-02-02 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 9 yrs postop the initial implant, this (b)(6) y/o female patient presented with a worn-out right knee patella and patella tracking issue.The patella was replaced as well as the pe insert.The insitu patella was worn down to the bone on both sides and the pe ps post had been snapped off the main body of the pe - exchange was performed at the same time of surgery.All pieces of the patella were removed.Patient was last known to be in stable condition following the event.Devices are to be returned.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of both patella wear and tibial spine fracture.The prosthesis wear was likely the result of years of articulation of the femoral component on an undersized patella, which led to patella wear.The prosthesis fracture may have been due to excessive loading contact between the femoral component and the tibial spine, which may have allowed for offset/asymmetrical contact between the femoral cam and the ps tibial spine and precipitated the fracture of the tibial spine.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "prosthesis fracture¿ is associated with a partial or full-thickness crack in the device materials, either during implantation or sometime after.Do not use if broken device is a screw.Furthermore, the most probable root cause associated with 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.
Additional Manufacturer Narrative
Section h11: the following sections have corrected information: (h3) the revision reported was likely the result of prosthesis wear and tibial spine fracture.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The patella wear was likely the result of years of articulation of the femoral component on an undersized patella, which contributed to patella wear.The prosthesis fracture was likely the result of contact between the femoral component and the anterior aspect of the tibial spine.The contact was likely due to hyperextension, which led to increased stress on the anterior of the spine and subsequent fracture.

• Brand Name: PS TIBIAL INSERTS SZ 2, 13MM
• 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: 12908614
• Report Number: 1038671-2021-00645
• Device Sequence Number: 4840093
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 204-22-13
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2024

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: 04/02/2020
• Device Model Number: PS TIBIAL INSERTS SZ 2, 13MM
• Device Catalogue Number: 204-22-13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 07/22/2022; Not provided
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 08/18/2022; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 76 KG