MAUDE Adverse Event Report: EXACTECH, INC. KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

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 bone fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Concomitant medical products: 01-040-01-0254 - logical g-series cup shell 3 hole sz 54c, 82340; 01-041-01-0236 - logical xlpe liner neutral sz 36c, 85d7a-2; 01-041-50-6525 - logical cup bone screw 25mm, 83fbd, 861ac-1; 01-045-00-3600 - femoral head ceramic 36mm (m, +0mm), 84c5e-1.

Event Description

It was reported that a 71 yo female that had a total hip replacement on (b)(6) 2022, showed up to her two week appointment unable to bear weight and in a wheel chair.It is stated that the patient did not have a trauma and is overweight.The surgeon got an x-ray and noticed a noncomplete fracture of her calcar.The surgeon got a ct and can see the fracture clearly.The medical plan is to limit weight bearing for 8 weeks hoping for fracture to heal and stem to stabilize.No other information.

Manufacturer Narrative

H3: 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 bone fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Additional information: patient did not have a fall and the only comorbidity i know of was being overweight.

• Brand Name: KNEE COMPONENTS
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15675277
• MDR Text Key: 302469445
• Report Number: 1038671-2022-01353
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/05/2022
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female