MAUDE Adverse Event Report: ENCORE MEDICAL L.P SLIDING CORE, UHMPWE, 10MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400-144F

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

Patient Problem Failure of Implant (1924)

Event Date 01/18/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, independent sales representative, emailed fa inventory requesting a star tray and implant bank for a star total ankle poly exchange case on (b)(6) 2024 at mercyone west lakes hospital on a 66 year old male patient (dob:(b)(6) 1957).Regional account coordinator, followed up with independent sales representative, regarding case details.She stated the patient "has had star for 11 years and 2 polys (400-144f, sliding core, uhmpwe, 10mm) have broke within 11 years".Independent sales representative reported that the patient was compliant however has comorbidities including dvt, ed, gerd, and hypertension.It is unknown when the 1st 400-144f broke.

Manufacturer Narrative

The reason for the revision surgery on (b)(6) 2024, independent sales representative, emailed fa inventory requesting a star tray and implant bank for a star total ankle poly exchange case on (b)(6) 2024 at mercyone west lakes hospital on a 66 year old male patient (dob:(b)(6) 1957).Regional account coordinator, followed up with independent sales representative, regarding case details.She stated the patient "has had star for 11 years and 2 polys (400-144f, sliding core, uhmpwe, 10mm) have broke within 11 years".Independent sales representative reported that the patient was compliant however has comorbidities including dvt, ed, gerd, and hypertension.It is unknown when the 1st 400-144f broke.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: SLIDING CORE, UHMPWE, 10MM
• 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: 18708165
• MDR Text Key: 335405591
• Report Number: 1644408-2024-00126
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400-144F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG