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

Catalog Number	33680023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Impaired Healing (2378); Post Operative Wound Infection (2446)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
After patient underwent a debridement and irrigation with a poly swap, the patients condition improved.However, a couple of weeks later the patient worsened and had incomplete healing of the tendon exposure.Irrigation debridement of the superficial skin.If it appeared to be deeply infected and a revision surgery was performed to remove the implants and insert an antibiotic implant along with a wound vac and synovectomy of extensor tendon.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
After patient underwent a debridement and irrigation with a poly swap, the patients condition improved.However, a couple of weeks later the patient worsened and had incomplete healing of the tendon exposure.Irrigation debridement of the superficial skin.If it appeared to be deeply infected and a revision surgery was performed to remove the implants and insert an antibiotic implant along with a wound vac and synovectomy of extensor tendon.
Additional 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.

• Brand Name: INFINITY¿ ADAPTIS TOTAL ANKLE SYSTEM
• Common Device Name: 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: 13501980
• Report Number: 3010667733-2022-00055
• Device Sequence Number: 3743658
• Product Code: HSN
• UDI-Device Identifier: 00889797101547
• UDI-Public: 00889797101547
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680023
• Device Lot Number: 1693586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 79 KG