MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 4 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33654406
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "increasing pain in left ankle.Progressive deterioration in left ankle causing increasing pain when mobilising.X-rays showing more lucency around tibia & talar components.Bloods taken for inflammatory markers.Ct re-performed showing cystic change in both tibia & talus.Listed for revision surgery.".
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.Device disposition unknown.
Additional Manufacturer Narrative
The complaint could be confirmed, since the information for evaluation matches the alleged failure, as pain is mentioned in the received report.Investigator reviewed the received information and noted: patient left ankle increasing pain when mobilizing got reported, listed for revision surgery.Based to the reporter this is not due to product problem, ct re-performed showing cystic change in both tibia & talus.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: "increasing pain in left ankle.Progressive deterioration in left ankle causing increasing pain when mobilising.X-rays showing more lucency around tibia & talar components.Bloods taken for inflammatory markers.Ct re-performed showing cystic change in both tibia & talus.Listed for revision surgery.".

• Brand Name: INFINITY POLY SZ 4 6MM 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19315881
• Report Number: 3010667733-2024-00298
• Device Sequence Number: 20585473
• Product Code: HSN
• UDI-Device Identifier: 00840420122780
• UDI-Public: 00840420122780
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 03/25/2025
• Device Catalogue Number: 33654406
• Device Lot Number: 1590829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 91 KG