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

Model Number 33630023

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Implant Pain (4561); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient may need to undergo a revision surgery for reasons that were not available at the time of this report.

Manufacturer Narrative

Correction: h6 device code, h6 method code and h6 clinical code the complaint couldn't be confirmed, since the returned image for evaluation don't matches the alleged failure.Medical profession reviewed the received information and noted: the clinical information of pain on weightbearing and the 99mtc-hdp bone scan revealing high activity caudal to the talar component are indeed most likely due to aseptic loosening of the talar component.The implant as such looks in order, and it is well implanted.No other abnormalities can be found.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient may need to undergo a revision surgery due to the patient having a lot of pain which persisted despite appearance of union of previously sustained medial malleolear fracture.Additional 531 mbq 99mtc-hdp bone scan revealed high activity caudal to the talar component most likely due to aseptic loosening.

• Brand Name: INFINITY¿ TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14848479
• MDR Text Key: 294910620
• Report Number: 3010667733-2022-00229
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122049
• UDI-Public: 00840420122049
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 33630023
• Device Catalogue Number: 33630023
• Device Lot Number: 1697704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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; Hospitalization