MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROPHECY® INFINITY® PATIENT SPECIFIC GUIDES; SMALL JOINT COMPONENT

Lot Number 1581805

Device Problems Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that intra-operative complications occurred that were related to a combination of implant sizing (bone coverage), implant placement (positioning), the rotational correction from valgus, struggles with imbalanced soft tissues resulting from the planned deformity correction, and the translation of the talus bone (positioning).The tibia and talus implants did not have the desired coverage, multiple recuts were required on the talus, and the coronal deformity (correction from valgus) did not correct as easily as expected.The surgeon stated that "ligament balancing may be necessary to achieve balance." no further information is known at this time.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: PROPHECY® INFINITY® PATIENT SPECIFIC GUIDES
• Type of Device: SMALL JOINT COMPONENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901451-631
• MDR Report Key: 5872498
• MDR Text Key: 52990693
• Report Number: 1043534-2016-00076
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123954
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 1581805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1