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 09/12/2023

Event Type  Injury  

Event Description

On, 09/11/2023, - regional director, notified regional account coordinator, of an upcoming star poly swap case with progressive medical on (b)(6) 2023.The account coordinator reached out to progressive medical solutions principal stated independent sales representative, would be present at the case with (b)(6) (b)(6) 2023 the account coordinator sent a follow up email the independent sales representative to provide the exponent retrieval kit request form and request additional case details such as original implant information, the reason for the poly swap and patient details.Independent sales representative sent the retrieval kit request form to the account coordinator which stated that the reason for the revision was "cracked poly" and that the original case was in 2015.In an additional email, independent sales representative sent hospital documentation that stated the patient is a 66 year old male.

Manufacturer Narrative

The reason for this revision surgery , on, 09/11/2023, - regional director, notified regional account coordinator, of an upcoming star poly swap case with progressive medical on (b)(6) 2023.The account coordinator reached out to progressive medical solutions principal stated independent sales representative, would be present at the case with (b)(6) on (b)(6) 2023.The account coordinator sent a follow up email the independent sales representative to provide the exponent retrieval kit request form and request additional case details such as original implant information, the reason for the poly swap and patient details.Independent sales representative sent the retrieval kit request form to the account coordinator which stated that the reason for the revision was "cracked poly" and that the original case was in 2015.In an additional email, independent sales representative sent hospital documentation that stated the patient is a 66 year old male.There were four similar complaints identified for the star poly component breaking.Previous complaints (b)(4) were investigated and documented by stryker, so the root cause remains unknown.Additionally, the root cause for similar complaint (b)(4) remains unknown.Thus, 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.It is unknown if the doctor followed the surgical technique with the limited information available and the original implantation occurring approximately 11 years ago.The broken poly was not returned, so visual and dimensional inspection did not occur.Simulated use testing did not occur.The reporter stated the original poly "broke" but did not provide any photographs or x-rays.Based on the limited information available regarding original implantation technique and physiological changes during implantation, as well as the poly not being returned, the root cause shall remain as unknown.

• 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: 18654417
• MDR Text Key: 334698969
• Report Number: 1644408-2024-00208
• 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: 09/12/2023
• 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: 66 YR
• Patient Sex: Male