MAUDE Adverse Event Report: ENCORE MEDICAL L.P. STAR, SLIDING CORE, UHMPWE, 8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400-142F

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

Patient Problem Failure of Implant (1924)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

Notes to form 3500a and justification for information not provided as required per 21cfr803.52 is below.Trilliant surgical attempted to obtain the omitted information (items 1-10 below) as part of internal complaint handling activities.Serial/lot # (d4) used in surgery unknown.Information not provided is not available to the reporter expiration date (d4) unknown as lot # could not be confirmed.Information not provided is not available to the reporter preprocessor name and address (d7) n/a to this report.Device 510k is unknown section g7 n/a to this report.Section h9 n/a to this report.No files attached to this report.Nvestigation on 12/07/2023, enovis customer care received a delivered goods form (dgf) for a star total ankle revision case, allegedly due to wearing of the poly due to the patient dislocating their ankle several years ago secondary to rheumatoid arthritis.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 poly was "was worn down due to the patient dislocating their ankle several years ago secondary to rheumatoid arthritis." based on the limited information and the poly not being returned to the houston site, the root cause shall remain as unknown.

Event Description

On (b)(6) 2023, enovis customer care received a delivered goods form (dgf) for a star total ankle revision case, allegedly due to wearing of the poly due to the patient dislocating their ankle several years ago secondary to rheumatoid arthritis.

• Brand Name: STAR, SLIDING CORE, UHMPWE, 8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: justin lovelace ; 727 north shepherd drive, suite 100; houston, TX 77007
• MDR Report Key: 18460602
• MDR Text Key: 332255477
• Report Number: 1644408-2024-00036
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 400-142F
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/07/2023
• 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: 70 YR
• Patient Sex: Male