MAUDE Adverse Event Report: ENCORE MEDICAL L.P STAR TOTAL ANKLE; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNKNOWN

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

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 12/22/2023

Event Type  Injury  

Event Description

On 01/31/2024, quality engineer, emailed fa complaints regarding a fda medwatch report that was submitted via patient to the fda on 01/08/2024.The report states "i started having pain when walking and saw and medical professional, who sent me to have x-rays.The x-ray report stated particle disease.The orthopedic doctor ordered a cat(computed axial tomography) scan.I will have to have a replacement surgery.The particle disease is directly from the star ankle replacement.The palmore plastic is breaking off.I will be having a cat scan with contrast to see what type of damage there really is." (b)(4) reached out to the patient requesting additional details such as the original procedure information (facility, surgeon), patient information (age, dob, weight, bone quality, activity level, comorbidities, and non compliance), product information (part number of implants) and possible removal surgery information (date, x-rays) but has not received a response at this time.At the time of the report dated 01/08/2023, the star total ankle remained in the patient.

Manufacturer Narrative

On 01/31/2024, quality engineer, emailed fa complaints regarding a fda medwatch report that was submitted via patient to the fda on 01/08/2024.The report states "i started having pain when walking and saw and medical professional, who sent me to have x-rays.The x-ray report stated particle disease.The orthopedic doctor ordered a cat(computed axial tomography) scan.I will have to have a replacement surgery.The particle disease is directly from the star ankle replacement.The palmore plastic is breaking off.I will be having a cat scan with contrast to see what type of damage there really is." (b)(4) reached out to the patient requesting additional details such as the original procedure information (facility, surgeon), patient information (age, dob, weight, bone quality, activity level, comorbidities, and non compliance), product information (part number of implants) and possible removal surgery information (date, x-rays) but has not received a response at this time.At the time of the report dated 01/08/2023, the star total ankle remained in the patient.There were 7 similar complaints identified for star poly component damage.The previous complaints do not aid in the investigation for this complaint, (b)(4).Dhr review was not conducted due to the complaint part not being returned and the lot number remaining unknown.The poly was not returned to the houston site, so visual and dimensional inspection did not occur.Simulated use testing did not occur.Per the reporter, "the patient has had star for 11 years and 2 polys (400-144f, sliding core, uhmpwe, 10mm) have broken within 11 years".It is unknown when the first poly broke, and the date the second poly was implanted.The provided x-rays confirm the poly is broken and no longer in the correct configuration compared to star ankle total ankle surgical technique, mk-10347 rev 0.(figures 1-2).The reporter stated the patient was compliant.Based on the limited information regarding the date of implantation and the poly not being returned to the houston site, the root cause shall remain as unknown.

• Brand Name: STAR TOTAL ANKLE
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18789760
• MDR Text Key: 336395310
• Report Number: 1644408-2024-00239
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Female