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

Model Number 33650005

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, at an unknown time after the original total ankle surgery, patient returned to surgeon and revision total arthroplasty was prescribed.The surgeon noted that the tibia bone showed significant loss of density around the implant, with implant subsidence pointing to implant loosening.A different system was used in the revision surgery.Intra-op, the surgeon noted that both the tibia and talus had poor bone ongrowth and the bone quality had degraded.Four cultures, including one "deep ankle," were sent to the lab intra-op, but no infection was found.

• Brand Name: INFINITY®
• 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: 1023 cherry road; 901451-631
• MDR Report Key: 7525629
• MDR Text Key: 108631771
• Report Number: 1043534-2018-00037
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140749
• 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
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33650005
• Device Lot Number: 1584168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/20/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: POLY INSERT
• Patient Outcome(s): Required Intervention