MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680023
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Dislocation (2374); Limb Fracture (4518); Joint Laxity (4526); Implant Pain (4561)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device was discarded.
Event or Problem Description
It was reported that the patient had an infinity total ankle system implanted on (b)(6) 2021.It was noted that "the top fell off his leg and the bottom fell off his ankle." it was reported as dislodged.The patient waited 6 months and then underwent a revision procedure.
Event or Problem Description
It was reported that the patient had an infinity total ankle system implanted on (b)(6) 2021.It was noted that "the top fell off his leg and the bottom fell off his ankle." it was reported as dislodged.The patient waited 6 months and then underwent a revision procedure.
Additional Manufacturer Narrative
Correction - h6 (clinical signs code, device code).The reported event could not be confirmed based on review of provided information.However, implant -loosening postoperative was confirmed based on information documented by the treating surgeon and by review of available imaging by medical affairs.Review of documents provided indicated the patient presented with right total ankle loosening, right lateral ankle instability, stress fracture right medial malleolus.The patient underwent a right total ankle replacement revision, right lateral ankle ligament reconstruction, right medial malleolus fixation.Findings: tibial and talar component were both loose.Medical affairs reviewed the available information and confirmed the op report statements and no issues with the construct was noted.It was also noted the patient, "has a complex foot and ankle deformity with a previous double arthrodesis to correct the fixed flatfoot deformity.He underwent a infinity total ankle placement and had some initial success but then with increasing pain." the current instructions for use list as a potential adverse effect, "prosthetic components can loosen or migrate due to trauma or loss of fixation" and list as potential late postoperative complications, "pain;.Bone fracture by trauma or excessive loading, particularly in the presence of poor bone stock".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 ADAPTIS TALDOME SZ3 INFINITY ADAPTIS
• 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: 17725777
• Report Number: 3010667733-2023-00523
• Device Sequence Number: 7163390
• Product Code: HSN
• UDI-Device Identifier: 00889797101547
• UDI-Public: 00889797101547
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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 Catalogue Number: 33680023
• Device Lot Number: 1693586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG