MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L; HIP BALL HEAD

Catalog Number	01.29.206
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2024: lot 2211901: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-24.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.Clinical evaluation performed by medical affair director: a dislocation was reported a few months after the primary implantation of a total hip arthroplasty (tha).The available images clearly confirm the dislocation and also reveal a slightly undersized stem, with possible mobilization visible on the dislocation x-ray.Additionally, a bony defect is evident on the superior aspect of the acetabulum, along with a displaced bone fragment.Hip dislocation is a well-known complication following tha and can result from component positioning or insufficient soft tissue tensioning.In this case, the presence of the acetabular defect may have compromised the competence of the soft tissue envelope, contributing to the dislocation.It is unlikely that the dislocation can be attributed to the standard devices used.Additional implant involved, batch review performed on 02 september 2024: liner: mectacer 01.29.409 ceramic liner ø 32 / d lot 2006662: (b)(4) items manufactured and released on 25-sep-2020.Expiration date: 2025-09-16.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.Item not registered in us.
Event or Problem Description
Revision surgery due to hip luxation at about 5 months post primary.

• Brand Name: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L
• 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: 20320101
• Report Number: 3005180920-2024-00763
• Device Sequence Number: 7782968
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: 01.29.206
• Device Lot Number: 2211901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian