MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TIBIAL TRAY SZ 4 LNG TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33650014

Device Problem Loss of Osseointegration (2408)

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

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Device remains implanted.If additional information becomes available, it will be provided on a supplemental report.Device not available remains implanted.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Sometime post-op it was discovered that the patient may need to undergo a revision surgery due to loosening of the tibial component.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences of sufficient quality were provided.A medical professional reviewed the information an radiographic images provided.Per their review, "looking at the slices from the ct scan, there may indeed be loosening of the tial tray, since there seems to be an area of black around the tibial tray, this maybe indicative for loosening.Although we have to keep in mind these are just two slices of the scan, and the quality is low." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Sometime post-op it was discovered that the patient may need to undergo a revision surgery due to loosening of the tibial component.

• Brand Name: INFINITY TIBIAL TRAY SZ 4 LNG TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 11987171
• MDR Text Key: 255975123
• Report Number: 0001043534-2021-00099
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122551
• UDI-Public: 00840420122551
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33650014
• Device Catalogue Number: 33650014
• Device Lot Number: 1685360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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): Required Intervention