MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY POLY SZ 3+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33654307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Necrosis (1971)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "patient had wound infection.Presented at clinic six weeks post op with poor healing.There was a 2x1cm section of necrotic tissue.Oral antibiotics commenced and referred to plastic team.Admitted for wound washout and split skin graft.Ankle joint aspiration completed on (b)(6) 2017 with no growth on direct culture.".
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.Sterility assurance reviewed sterility documents and noted: no holds were placed on this lot, and ongoing bioburden testing was within specifications.Furthermore, this product expired in may 2022, and no other associated complaints, ncs or capas were associated with this lot.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient had wound infection.Presented at clinic six weeks post op with poor healing.There was a 2x1cm section of necrotic tissue.Oral antibiotics commenced and referred to plastic team.Admitted for wound washout and split skin graft.Ankle joint aspiration completed on (b)(6) 2017 with no growth on direct culture.".

• Brand Name: INFINITY POLY SZ 3+ 7MM TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• 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: 19696953
• Report Number: 3010667733-2024-00420
• Device Sequence Number: 8066617
• Product Code: HSN
• UDI-Device Identifier: 00840420122742
• UDI-Public: 00840420122742
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 05/31/2022
• Device Catalogue Number: 33654307
• Device Lot Number: 1541552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2014
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 97 KG