MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROPHECY INFINITY; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number PROPINFE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog #: propinf, 510k #: k131283 was cleared in the united states.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the talar guide was manufactured incorrectly and did not match the ct scans.The report image of talar neck was different to the ct scan, showing osteophytes and voids that weren't on the ct scan.This resulted in the psi guide not sitting flush with the talus bone.More bone was taken from the tibia, resulting in the surgeon having to place a medial malleolus plate on the tibia as a preventative for potential fracture.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the talar guide was manufactured incorrectly and did not match the ct scans.The report image of talar neck was different to the ct scan, showing osteophytes and voids that weren't on the ct scan.This resulted in the psi guide not sitting flush with the talus bone.More bone was taken from the tibia, resulting in the surgeon having to place a medial malleolus plate on the tibia as a preventative for potential fracture.

Manufacturer Narrative

G4: this part is not approved for use in the united states; however a like device catalog # propinf, 510k # k131283 was cleared in the united states.H6: the products were not returned; however, images were provided that show the guides in situ during the operation.A post revision radiographic image was also provided.Evaluation of the image does find infinity devices in vivo and a medial malleolus plate and screws.

• Brand Name: PROPHECY INFINITY
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11585794
• MDR Text Key: 244162653
• Report Number: 1043534-2021-00046
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: PROPINFE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR