MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XE; HIP FEMORAL HEAD

Catalog Number	01.29.211
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent primary surgery on (b)(6) 2022.On (b)(6) 2022, the patient has been revised the first time because of surgical wound issues.Ceramic ball head ø36 size xl and liner ø36/e revised successfully and the surgeon implanted ceramic ball head (ø36 size xl) and pe liner.On (b)(6) 2022, the patient underwent a second revision surgery due to joint luxation.Ball head, liner and acetabular shell have been successfully revised and versafitcup dm ø58mm, liner dm ø28/58mm dmi and cocr ball head ø28 size xl (+7) were implanted.
Additional Manufacturer Narrative
Batch review performed on 18 april 2024.Lot 21c0054: (b)(4) manufactured and released on 26-oct-2021.Expiration date: 2026-10-10.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported event during the period of review.Additional component involved in the event: liner: versafitcup cc trio 01.26.3644hct flat pe hc liner ø 36 / e (k1033529) lot 2118278: 128 items manufactured and released on 12-jan-2022.Expiration date: 2026-12-22.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XE
• Common Device Name: HIP FEMORAL 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: 19267220
• Report Number: 3005180920-2024-00289
• Device Sequence Number: 6981111
• Product Code: LZO
• UDI-Device Identifier: 07630030809224
• UDI-Public: 07630030809224
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/08/2024

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: 01.29.211
• Device Lot Number: 21C0054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 115 KG