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

Model Number PROPINF

Device Problem Component Incompatible (1108)

Patient Problem No Code Available (3191)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

Lot: 1607645 was sent for surgery however lot 1607717 was custom made for patient.(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation.

Event Description

It was reported that the patient underwent an ankle surgical procedure.Allegedly, the custom cut guides for the case were provided for the wrong patient.This was not noticed until the surgeon was trying to seat the tibia cut guide on the patient.The case was aborted and the patient was admitted for the weekend for the case to be completed on a monday morning.No additional patient complications were reported.

Manufacturer Narrative

The parts were returned and confirm that guides were swapped (i.E labeling did not match contents).Examination of the returned parts does not change the findings from the previous investigation.

• Brand Name: PROPHECY® INFINITY® PATIENT SPECIFIC GUIDES
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry road; 901451-631
• MDR Report Key: 6750036
• MDR Text Key: 81255153
• Report Number: 1043534-2017-00082
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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
• Device Operator: Other
• Device Expiration Date: 01/05/2018
• Device Model Number: PROPINF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/17/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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): Other