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

Model Number	33684309
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient came into surgeons office with swelling and redness.The surgeon attempted to treat by aspirating the ankle and treated with antibiotics.Infection persisted, so the surgeon removed the prosthesis and replaced it with an antibiotic spacer.Due to infection and tibial loosening, patient required explantation of prosthesis, implantation of antibiotic cement spacer, and will require a revision.
Additional Manufacturer Narrative
Correction h6 device code, method code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention and the aftercare.Instruments or implants may become contaminated or flaws in decontamination can occur.This may lead to unsterile instruments or implants.These should not be used.If it goes unnoticed, the use of these devices may cause infection.A medical professional reviewed the received information and noted the following: "i agree that in this case the clinical working hypothesis is a deep, periprosthetic joint infection (pji).This can be concluded from the sparse information.A definitive diagnosis can be confirmed with information of the tissue cultures (if any) that were most likely taken during explantation of the device.Yet, explantation and leaving behind antibiotics-loaden cement spacer, is usually solely done for the two-stage treatment of a pji." 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 or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient came into surgeons office with swelling and redness.The surgeon attempted to treat by aspirating the ankle and treated with antibiotics.Infection persisted, so the surgeon removed the prosthesis and replaced it with an antibiotic spacer.Due to infection and tibial loosening, patient required explantation of prosthesis, implantation of antibiotic cement spacer, and will require a revision.

• Brand Name: INFINITY¿ EVERLAST
• 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: 15059745
• Report Number: 3010667733-2022-00252
• Device Sequence Number: 14835061
• Product Code: HSN
• UDI-Device Identifier: 00889797074568
• UDI-Public: 00889797074568
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 33684309
• Device Catalogue Number: 33684309
• Device Lot Number: 1716580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male