MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 4+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33685407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had original implant removed due to infection that was unrelated to the total ankle surgery.Implant was removed and antibiotic cement spacer was inserted.Oral antibiotics prescribed.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient had original implant removed due to infection that was unrelated to the total ankle surgery.Implant was removed and antibiotic cement spacer was inserted.Oral antibiotics prescribed.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available medical records and health care professional opinions.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿contraindications include: infection at the ankle site or infections at distant sites that could migrate to the ankle.¿ formal medical opinion was sought from an experienced independent medical expert, and he opined as below- ¿the implant is removed.There is cement inserted in the area of the former joint.No implant visible.The finding in the ct-scan is consistent with the given information (¿patient had original implant removed due to infection that was unrelated to the total ankle surgery.Implant was removed and antibiotic cement spacer was inserted.¿)¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused by infection which in turn leads to implant removal and cement spacer inserted in former joint.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY EVERLAST SZ 4+ 7MM 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: 16268919
• Report Number: 3010667733-2023-00049
• Device Sequence Number: 6522537
• Product Code: HSN
• UDI-Device Identifier: 00889797074636
• UDI-Public: 00889797074636
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 33685407
• Device Catalogue Number: 33685407
• Device Lot Number: 1677701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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
• Patient Age: 71 YR
• Patient Sex: Male