MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S; HIP CERAMIC BALL HEAD

Model Number	01.29.212
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 august 2020: lot 1906477: (b)(4) items manufactured and released on 30-oct-2019.Expiration date: 2024-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional device involved: batch review performed on 06 august 2020: liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot 1906072: (b)(4) items manufactured and released on 09-aug-2019.Expiration date: 2024-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During post-op recovery, the patient's liner dislocated from the head.The day after primary surgery the surgeon revised the head and the surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE S
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10452932
• Report Number: 3005180920-2020-00542
• Device Sequence Number: 19714025
• Product Code: LZO
• UDI-Device Identifier: 07630030809231
• UDI-Public: 07630030809231
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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 Expiration Date: 10/20/2024
• Device Model Number: 01.29.212
• Device Catalogue Number: 01.29.212
• Device Lot Number: 1906477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention