MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	204-25-11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
On (b)(6) 2013, a (b)(6) y/o, male patient with a bmi of 37.7, underwent implantation of a insert tib 5 11mm knee post stab optet.On (b)(6) 2019, approximately 70 months post implant, the patient underwent revision due to osteolysis.
Additional Manufacturer Narrative
(h3) based on review of all available information, there is no evidence of the contribution of the devices to the experience reported and it could not be determined as the device was not returned for evaluation.The cause of the revision could not be conclusively determined due to the revision reported was not provided; however, it is most likely the result of the patient¿s underlying condition.Ifu #700-096-004 states: device specific risks - fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Patients should be informed that their weight and activity level may affect the longevity of the implant.Patients should be advised to report any pain, decrease in range of motion, swelling, fever, or unusual sounds (e.G.Clicking) as this may indicate positional changes in the implant that could lead to premature failure.

• Brand Name: PS TIBIAL INSERTS SZ 5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10389010
• Report Number: 1038671-2020-00441
• Device Sequence Number: 1896491
• Product Code: JWH
• UDI-Device Identifier: 10885862048479
• UDI-Public: 10885862048479
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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 Model Number: 204-25-11
• Device Catalogue Number: 204-25-11
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 73 YR