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

Catalog Number	400-144F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2024-00126
• Device Sequence Number: 8518219
• Product Code: NTG
• UDI-Device Identifier: 00886385026961
• UDI-Public: 00886385026961
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 400-144F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG