MAUDE Adverse Event Report: EXACTECH, INC. THREE PEG PATELLA 35MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	PS TIBIAL INSERTS SZ 3, 13MM-1871888
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 204-23-13 ps tibial inserts sz 3, 13mm-1871888.Device discarded by the customer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a (b)(6) male, initially implanted (b)(6) 2018 on the left side, had a revision approximately 3 years 10 months post initial implant, to exchange the patella and poly due to wear.The patient was revised to exactech devices.Patient was last known to be in stable condition following the event.The explanted devices were discarded by the facility and are not available for return.
Additional Manufacturer Narrative
H6: the revision reported was likely the result of prosthesis wear consistent with oxidative degeneration of the polyethylene.Contributing factors to the severity of the wear on the tibial insert may have been result of being packaged in a non-conforming vacuum bag for more than five years and instability of the knee.However, this cannot be confirmed as the devices were not available for evaluation.D4: product information,.

• Brand Name: THREE PEG PATELLA 35MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 15053025
• Report Number: 1038671-2022-00812
• Device Sequence Number: 5489676
• Product Code: JWH
• UDI-Device Identifier: 10885862048325
• UDI-Public: 10885862048325
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2018
• Device Model Number: PS TIBIAL INSERTS SZ 3, 13MM-1871888
• Device Catalogue Number: 204-23-13
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2010
• 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: 200-02-35 - THREE PEG PATELLA 35MM - 5310303; SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG