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

Catalog Number 33680013

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

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Erythema (1840); Post Operative Wound Infection (2446); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that the patient had postoperative wound dehiscence in a small area with no drainage.The patient was advised to wash the area with soap and water and maintain a dry dressing applied to wound dehiscence.Eight days later it was found that the area was worsening and inspection found moderate erythema with purulent drainage.There was also moderate swelling.Palpation tenderness around the incisional area.Patient is digressing with worsening pain redness and drainage.The patient was taken to the operating room for left ankle revision with irrigation debridement and a polyethylene exchange.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could be confirmed, since operative notes were provided for evaluation and match the alleged failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing, or design-related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert as below: ¿the surgeon has treated the patient very well.The patient was well informed and able to decide on the extend of the treatment as well.The surgeon examined the wound and the surgical field in a detailed manner and even though there were no definitive signs of a deep infection, he did the right thing of debridement, exchange of the modular component (pe-liner) and antibiotics (dair-procedure).A state-of-the-art approach one can say.The infection was probably related to the wound healing disorder, but the presence of a total ankle arthroplasty device influences the course of such a disorder, since once the dair-procedure was done, the prolonged wound healing problems (open wound) most likely made the chances of the implanted getting contaminated higher.¿ based on the investigation and medical expert¿s opinion, the root cause was attributed to patient related factors i.E.Wound healing disorder.The presence of a total ankle arthroplasty device also influences the course of such a disorder since once the dair procedure was done, the prolonged wound healing problems (open wound) most likely made the chances of the implanted getting contaminated higher.If any further information is provided, the complaint report will be updated.

Event Description

It was reported that the patient had postoperative wound dehiscence in a small area with no drainage.The patient was advised to wash the area with soap and water and maintain a dry dressing applied to wound dehiscence.Eight days later it was found that the area was worsening and inspection found moderate erythema with purulent drainage.There was also moderate swelling.Palpation tenderness around the incisional area.Patient is digressing with worsening pain redness and drainage.The patient was taken to the operating room for left ankle revision with irrigation debridement and a polyethylene exchange.

• Brand Name: INFINITY¿ ADAPTIS 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: 13501762
• MDR Text Key: 285552500
• Report Number: 3010667733-2022-00050
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069687
• UDI-Public: 00889797069687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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: 33680013
• Device Lot Number: 1701193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 79 KG