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

Catalog Number UNKNOWN

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

Patient Problem Failure of Implant (1924)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery, on 08/28/2023, regional sales director, emailed regional account coordinator, requesting an exponent retrieval kit for a star total ankle poly swap case on (b)(6) 2023 at (b)(6) hospital.Regional account coordinator followed up with independent sales representative, who will be present at the case on (b)(6) 2023 to obtain additional case details such as patient information, original implant/case information and details regarding why the star total ankle poly swap is necessary.Independent sales representative did not have any of the above information at this time but a follow up will take place after the case on (b)(6) 2023.The explanted poly (part # unknown) will be returned to exponent.There were 50 similar complaints identified for star poly swaps with no reported damage beyond normal wear.Previous complaints were investigated and documented by stryker prior to february 2023 and do not aid in investigation for this complaint.Similar complaints identified after february 2023 had a root cause of unknown and do not aid in the investigation for this complaint.Dhr review was not conducted due to the complaint part not being returned and the part and lot number remaining unknown.It is unknown if the doctor followed the surgical technique with the limited information available.The poly was not returned, so visual and dimensional inspection did not occur.Simulated use testing did not occur.Per the reporter, the initial poly was implanted "around 13 years ago.The patient had a fall or a bad step and heard a pop and was in pain after.The patient is in good health with great bone quality and normal activity levels.The poly was broken in half medial to lateral pretty much right in the middle." based on the information provided by the reporter, the root cause shall be attributed to patient-other due to breakage occurring as the result of a fall or bad step.

Event Description

On 08/28/2023, regional sales director, emailed regional account coordinator, requesting an exponent retrieval kit for a star total ankle poly swap case on (b)(6) 2023 at (b)(6) hospital.Regional account coordinator followed up with independent sales representative, who will be present at the case on (b)(6) 2023 to obtain additional case details such as patient information, original implant/case information and details regarding why the star total ankle poly swap is necessary.Independent sales representative did not have any of the above information at this time but a follow up will take place after the case on (b)(6) 2023.The explanted poly (part # unknown) will be returned to exponent.

• Brand Name: STAR
• 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: 18655616
• MDR Text Key: 334722084
• Report Number: 1644408-2024-00210
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 68 YR
• Patient Sex: Female