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

Model Number	33652208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient continued to have pain in the ankle following the surgery.Ct showed no evidence of significant loosening of the implants.Suspect bony impingement as likely cause of pain.Patient also noted to have end-stage talonavicular arthritis.Revision surgery took place to revise ankle implant with poly exchange and gutter cleanout, talonavicular joint fusion with calcaneus bone graft harvest.Subject continuing to improve since poly exchange surgery, follow-up yearly.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient continued to have pain in the ankle following the surgery.Ct showed no evidence of significant loosening of the implants.Suspect bony impingement as likely cause of pain.Patient also noted to have end-stage talonavicular arthritis.Revision surgery took place to revise ankle implant with poly exchange and gutter cleanout, talonavicular joint fusion with calcaneus bone graft harvest.Subject continuing to improve since poly exchange surgery, follow-up yearly.
Event or Problem Description
It was reported that the patient continued to have pain in the ankle following the surgery.Ct showed no evidence of significant loosening of the implants.Suspect bony impingement as likely cause of pain.Patient also noted to have end-stage talonavicular arthritis.Revision surgery took place to revise ankle implant with poly exchange and gutter cleanout, talonavicular joint fusion with calcaneus bone graft harvest.Subject continuing to improve since poly exchange surgery, follow-up yearly.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.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.

• Brand Name: INFINITY¿ 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12964552
• Report Number: 3010667733-2021-00003
• Device Sequence Number: 14500694
• Product Code: HSN
• UDI-Device Identifier: 00840420122636
• UDI-Public: 00840420122636
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/23/2026
• Device Model Number: 33652208
• Device Catalogue Number: 33652208
• Device Lot Number: 1627896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 76 KG