MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 4 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33654408

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

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Inflammation (1932); Swelling/ Edema (4577)

Event Date 02/10/2022

Event Type  Injury  

Event Description

It was reported during clinical follow up that the patient had "hot swollen right ankle, deep seated infection diagnosed.Emergency admission following a month history of swelling, redness and hot right ankle.Patient was taken to theatre on for a debridement and washout of abscess on anterior aspect of right ankle, followed by surgery on the following day for an exploration of lateral side of ankle (right) debridement curettage of cysts and insertion of stimulation plus ceremet.Treated with oral antibiotics for 3 months, infection then resolved.".

Manufacturer Narrative

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

Event Description

It was reported during clinical follow up that the patient had "hot swollen right ankle, deep seated infection diagnosed.Emergency admission following a month history of swelling, redness and hot right ankle.Patient was taken to theatre on for a debridement and washout of abscess on anterior aspect of right ankle, followed by surgery on the following day for an exploration of lateral side of ankle (right) debridement curettage of cysts and insertion of stimulation plus ceremet.Treated with oral antibiotics for 3 months, infection then resolved.".

Manufacturer Narrative

The reported event could be confirmed, based on available medical record and clinical report.The device inspection was not possible as the product was not returned 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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing clinical report and surgeon¿s feedback we can conclude that the event is not a revision case exactly, it is probably related to primary surgery.Deep infection is caused due to patient factor not device related.Medication is required to prevent life-threatening illness or injury, or permanent impairment or damage.Patient is treated with oral antibiotics for 3 months to resolve infection.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention, and the aftercare.Sterility test has been performed which met all the specifications.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY POLY SZ 4 8MM 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: 17730412
• MDR Text Key: 323199714
• Report Number: 3010667733-2023-00529
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122797
• UDI-Public: 00840420122797
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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: 33654408
• Device Lot Number: 1600489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• 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
• Patient Sex: Male
• Patient Weight: 82 KG