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

Model Number SEE H10

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Osteolysis (2377)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.The device has been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

Allegedly, there was osteolysis around tibial stem and loosening of implants with extreme metallosis.The implants were removed, wound debridement, irrigated, ria bone graft.

Manufacturer Narrative

The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, the suspect devices in use are part # 60004401, lot # 1559162; part #220220903, lot # 1591132; part #220224410e, lot # 1589091; part # 200011902, lot # 1555491; part #200011902, lot #1587361; part # 200010903, lot # 1546143; part # 200010903, lot # 0511339239; part # 200009902, lot # 1592958; and part # 200347901, lot # 1591702.Device evalauated by mfr: the implants were returned for evaluation.Visual examination of the returned devices does not show any overall gross deformation.There are a few scratches/dings which are consistent with removal during the revision surgery.The tibial tray and tibial stems have green bone cement on them.The tibial tray has the bone cement on the sides, and the tibial stems are completely incased in bone cement.Also, it was noted that there was bone cement in the morse taper of the base stem.

• Brand Name: INVISION
• 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: 7552462
• MDR Text Key: 109492932
• Report Number: 1043534-2018-00041
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/26/2018
• Patient Sequence Number: 1
• Treatment: INVISION TIBIAL TRAY; POLY; TALAR DOME; TIBIAL STEMS; INVISION TIBIAL TRAY; POLY; TALAR DOME; TIBIAL STEMS
• Patient Outcome(s): Required Intervention