MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; HIP BALL HEAD

Model Number	01.29.204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-oct-2024 lot 2402165: (b)(4) items manufactured and released on 09-feb-2024.Expiration date: 2029-01-23.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.Other device involved: liner: impact flat pe hc liner ø32/d (k103721) lot 2336922: (b)(4) items manufactured and released on 22-sept-2023.Expiration date: 2028-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.
Event or Problem Description
At about 2 months after the primary, the patient came in reporting pain due to a joint luxation and the cause is unknown.The surgeon revised the head, cup and liner.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: HIP BALL HEAD
• 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: 20539547
• Report Number: 3005180920-2024-00857
• Device Sequence Number: 8465711
• Product Code: LZO
• UDI-Device Identifier: 07630030809156
• UDI-Public: 07630030809156
• 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): 10/25/2024

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: 01.29.204
• Device Lot Number: 2402165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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: 66 YR
• Patient Sex: Female