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

Catalog Number 33680023

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Dislocation (2374); Limb Fracture (4518); Joint Laxity (4526); Implant Pain (4561)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device was discarded.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 323146218
• Report Number: 3010667733-2023-00523
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797101547
• UDI-Public: 00889797101547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680023
• Device Lot Number: 1693586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG