MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; FEMORAL HEAD Ø 40 SIZE XL

Model Number	01.29.215
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-dec-2024 lot 2109352: (b)(4) items manufactured and released on 12-nov-2021.Expiration date: 2026-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Conclusions: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2023.On (b)(6) 2024, the patient came in reporting pain due to an anteverted cup.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in reporting pain due to a hip subluxation (between medacta head and competitor liner) and the cause is unknown.The surgeon revised medacta head and competitor's liner and cup and the surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: FEMORAL HEAD Ø 40 SIZE XL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21033591
• Report Number: 3005180920-2024-01137
• Device Sequence Number: 19851293
• Product Code: LZO
• UDI-Device Identifier: 07630030809262
• UDI-Public: 07630030809262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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 Model Number: 01.29.215
• Device Lot Number: 2109352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2021
• 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: 61 YR
• Patient Sex: Male
• Patient Race: White