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

Catalog Number UNK_WWA

Device Problems Break (1069); Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery because the patient fell or had some kind of accident that caused one of the talar pegs to break.No additional information was available.

Manufacturer Narrative

The reported event could be confirmed based on available medical records and health care expert¿s opinion.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert, and he opined that- ¿the tibial component looks intact.The pe seems to be in place as far as this can be assessed with the ct.The breakage of the talar peg can be confirmed with the ct -scan provided.Therefore, the failure due to the accident can be confirmed.The accident and sustained fracture resulted in failure of the implant¿ based on investigation, the root cause was attributed to a patient related issue.Patient was involved in accident and sustained fracture which resulted in breakage of talar peg thereby contributing to failure of the implant.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.

Event Description

It was reported that the patient underwent a total ankle replacement.The patient was involved in a motor vehicle accident and sustained a lisfranc injury and affected the talar component of the total ankle.Due to the accident the patient underwent a revision procedure for the chamfer size one talus, size 1 8mm poly.The patient was implanted with an adaptis flat cut talus size 1 and an everlast size 1 poly 12mm.

• Brand Name: UNKNOWN INFINITY TOTAL ANKLE SYSTEM
• 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: 16010792
• MDR Text Key: 305776264
• Report Number: 3010667733-2022-00456
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG