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

Model Number 400-144F

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

Patient Problems Cyst(s) (1800); Implant Pain (4561)

Event Date 10/21/2022

Event Type  Injury  

Event Description

It was reported that there was a revision of a star sliding core total ankle implant.The patient came in reporting pain at tibial site.The surgeon noticed that there was a cyst forming at the top of the tibia and decide to remove the cyst and the 10mm poly.Due to removal the surgeon replaced the site with an 11mm poly, because there was space after they cut the cyst out.The surgeon did not report that the poly caused this and the original poly was intact.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded.

• 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 6313
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15840763
• MDR Text Key: 304090047
• Report Number: 0001644408-2022-03021
• Device Sequence Number: 1
• Product Code: NTG
• UDI-Device Identifier: 00886385026961
• UDI-Public: 00886385026961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400-144F
• Device Catalogue Number: 400144F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female