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

Catalog Number	400-142F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1644408-2024-00036
• Device Sequence Number: 14224927
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: 00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2024

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: 400-142F
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 70 YR
• Patient Sex: Male