MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 2+ 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33653206

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 09/19/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient's initial total ankle replacement was completed on (b)(6) 2019 and patient was compliant following this procedure.On (b)(6) 2019, patient did return for a follow-up appointment and reported draining.Surgeon had concern of a superficial skin infection, but did not see signs of a deep infection of the ankle joint.Patient was treated for the superficial skin infection and did subsequently have a superficial irrigation and debridement.At the 5 month follow-up appointment on (b)(6) 2019, the patient had been admitted to the hospital for a severe case of diverticulitis and required a partial cholectomy.Patient was very pleased with the progress at this point.

Event Description

It was reported that the patient's initial total ankle replacement was completed on (b)(6) 2019 and patient was compliant following this procedure.On (b)(6) 2019, patient did return for a follow-up appointment and reported draining.Surgeon had concern of a superficial skin infection, but did not see signs of a deep infection of the ankle joint.Patient was treated for the superficial skin infection and did subsequently have a superficial irrigation and debridement.At the 5 month follow-up appointment on (b)(6) 2019, the patient had been admitted to the hospital for a severe case of diverticulitis and required a partial cholectomy.Patient was very pleased with the progress at this point.

Manufacturer Narrative

The reported event could not be confirmed for infection due to the lack of additional clinical information.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the tibial component is severely displaced anteriorly and luxated with some large cysts adjacent to the prosthesis.A periprosthetic fracture is not visible, though.Loosening and migration can be confirmed for the tibial component.The pe cannot be assessed directly.There is no indirect sign of loosening or breakage, though.The talar component shows radiolucence and adjacent to the central part of the talar implant there is a very large cyst visible, which is destabilizing the foundation of the implant.This indicates loosening and subsidence.Infection cannot be assessed with the ct scan only.There is no information given, that any infection is present.There was a superficial infection treated shortly after the implantation 2019.There is no further information on any infection now.¿ this complaint record captures the reported superficial wound infection that occurred shortly after implantation.The revision was due to loosening and migration of the tibial and talar components which were captured under a previous complaint record.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY POLY SZ 2+ 6MM 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: 18030531
• MDR Text Key: 326861983
• Report Number: 3010667733-2023-00648
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33653206
• Device Lot Number: 1641836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• 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): Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG