MAUDE Adverse Event Report: EXACTECH, INC. STEM EXTENSION 22MM X 80 L.; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	STEM EXTENSION 22MM X 80 L.
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/08/2022
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
As reported, approximately 13.5 years post tka, this 80 y/o male patient experienced increasing pain and left leg no longer able to bear weight.Radiologically showed periprosthetic fracture with fracture of the femoral stem at the adapter/stem transition.Patient had a revision and the explant was preserved.No additional information available.
Additional Manufacturer Narrative
(h3) the revision reported may have been the result of femoral loosening overtime, which created a bending moment on the femoral stem extension and led to crack initiation, propagation, and ultimate fracture at the threaded junction of the femoral stem extension and a periprosthetic fracture.However, this cannot be confirmed as the devices were not returned for evaluation and photographs and x-rays were unable to be obtained.The most probable root cause associated with the reported event of "prosthesis fracture¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: STEM EXTENSION 22MM X 80 L.
• 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: 14173613
• Report Number: 1038671-2022-00447
• Device Sequence Number: 5011445
• Product Code: JWH
• UDI-Device Identifier: 10885862049391
• UDI-Public: 10885862049391
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K012251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: STEM EXTENSION 22MM X 80 L.
• Device Catalogue Number: 204-46-08
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2004
• 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: 80 YR
• Patient Sex: Male