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

Model Number 33652206

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 01/05/2022

Event Type  Injury  

Event Description

It was reported by the patient that the patient underwent a total ankle replacement.The surgery was successful in restoring full range of motion.However, the patients entire foot including toes, sole, and top of the foot up to about halfway up the scar is totally numb since the day of the surgery.Per the patient, "i have no way of knowing whether or not the numbness prevents me from fully feeling pain.I do feel touch.I have spoken to surgeons about the numbness and spent 5 months of 2-3 hour physical therapy sessions.No one has any resolution to decrease the numbness.I was sent to a neurologist and was told that although he could not test every nerve, he did not find a source of the numbness.I feel that the implant is pressing on a nerve as there is a feeling of fullness at the point of the implant.I have also had a hip replacement and i do not have any feelings of fullness in it and expected that it would be the same for the tar.".

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported by the patient that the patient underwent a total ankle replacement.The surgery was successful in restoring full range of motion.However, the patients entire foot including toes , sole, and top of the foot up to about halfway up the scar is totally numb since the day of the surgery.Per the patient, "i have no way of knowing whether or not the numbness prevents me from fully feeling pain.I do feel touch.I have spoken to surgeons about the numbness and spent 5 months of 2-3 hour physical therapy sessions.No one has any resolution to decrease the numbness.I was sent to a neurologist and was told that although he could not test every nerve, he did not find a source of the numbness.I feel that the implant is pressing on a nerve as there is a feeling of fullness at the point of the implant.I have also had a hip replacement and i do not have any feelings of fullness in it and expected that it would be the same for the tar.".

Manufacturer Narrative

Correction d1, h6 method, conclusion.The reported event could be confirmed with the help of the x-rays and medical report provided for investigation.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿peripheral neuropathies have been reported following total joint surgery.Subclinical nerve damage has been reported, and may occur as the result of surgical trauma.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿i conclude that the surgeon has treated the patient well.The patient was well informed preoperatively, and the total ankle replacement was put in after careful analysis of the patient¿s problems.Furthermore, the prosthesis was implanted in a technically correct way, and multiple x-rays over time showed good alignment and osteointegration.After returning to the doctor¿s office, the surgeon did a good analysis of the residual complaints of the patient.Yes, the attached medical report addresses the stated numbness.It is document that the patient had a preoperative dysesthesia (change of the character of skin sensation without signs of a certain nerve damage) of the foot in a sock-like distribution, and that this preexisting numbness got worse postoperatively.The sock-like distribution suggests polyneuropathy, a diffuse decrease in nerve function due to aging, certain medication or (hereditary and non-hereditary) disease.It is however unlikely that it is connected to the implantation of the device.The most likely factor in this documentation is waldenström¿s disease (a type of blood cancer), whereas peripheral neuropathy (numbness or a painful "pins and needles" sensation in the feet, legs, and hands) is one of its leading symptoms.¿ based on investigation and medical expert¿s opinion, the root cause was attributed primarily to patient factor related issue i.E.Preoperative dysesthesia (change of the character of skin sensation without signs of a certain nerve damage) of the foot in a sock-like distribution, and that this preexisting numbness got worse postoperatively.The most likely factor is waldenström¿s disease (a type of blood cancer), whereas peripheral neuropathy (numbness or a painful "pins and needles" sensation in the feet, legs, and hands) is one of its leading symptoms.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: 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: 13419042
• MDR Text Key: 286675499
• Report Number: 3010667733-2022-00034
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122629
• UDI-Public: 00840420122629
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140749
• 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: 05/16/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 33652206
• Device Catalogue Number: 33652206
• Device Lot Number: 1596620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2017
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 75 KG