MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number PS TIBIAL INSERTS SZ 3, 13MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products- tibial tray (cat# 204-04-33).3 peg patella 29mm (cat# 200-02-29).Femoral posterior stabilizer (cat# 234-02-03).As reported, approximately 11.5 years post initial left side total knee arthroplasty, the obese 70 y/o female patient was revised due to infection.The patient has bilateral knee replacements.The surgeon replaced the poly and patella as well as a washout.There were fragments of polyethylene present in the knee joint.There was no breakage of the device or surgery delay/prolongation of the revision procedure.The patient was revised to exactech devices.The patient was last known to be in stable condition following the event.Photos received.There are no x-rays available.The devices are not available for evaluation as devices were discarded by hospital.No further information available.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, bilateral knee replacements.Unique anatomy, obesity, or other condition that impacts the performance of the device.The device wear is most likely a problem 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.

Event Description

As reported, approximately 11.5 years post initial left side total knee arthroplasty, the obese 70 y/o female patient was revised due to infection.The patient has bilateral knee replacements.The surgeon replaced the poly and patella as well as a washout.There were fragments of polyethylene present in the knee joint.There was no breakage of the device or surgery delay/prolongation of the revision procedure.The patient was revised to exactech devices.The patient was last known to be in stable condition following the event.Photos received.There are no x-rays available.The devices are not available for evaluation as devices were discarded by hospital.No further information available.

• Brand Name: PS TIBIAL INSERTS SZ 3, 13MM
• Type of Device: 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: 15902552
• MDR Text Key: 304684137
• Report Number: 1038671-2022-01550
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862048325
• UDI-Public: 10885862048325
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K933610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PS TIBIAL INSERTS SZ 3, 13MM
• Device Catalogue Number: 204-23-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG