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

Model Number	01.29.211
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain due to a luxation of the head from the liner.At about 1 months post primary the surgeon revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 september 2024 lot 2311918: (b)(4) items manufactured and released on 14-jun-2023.Expiration date: 2028-05-29.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: mpact hooded pe hc liner ø36/f (k132879) lot 2308601: (b)(4) items manufactured and released on 19- may-2023.Expiration date: 2028-05-07.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.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: HIP 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: 20485135
• Report Number: 3005180920-2024-00842
• Device Sequence Number: 17047685
• Product Code: LZO
• UDI-Device Identifier: 07630030809224
• UDI-Public: 07630030809224
• 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): 10/18/2024

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: 01.29.211
• Device Lot Number: 2311918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White