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

Model Number	01.29.214
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 march 2021: lot 2004419: (b)(4) items manufactured and released on 06-aug-2020.Expiration date: 2025-07-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Another device involved: batch review performed on 04 march 2021: liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641), lot.2005019: (b)(4) items manufactured and released on 23-sep-2020.Expiration date: 2025-09-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the head 23 days after the primary surgery and the surgery was completed successfully.The liner was left in situ.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L
• Common Device Name: CERAMIC FEMORAL BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11562515
• Report Number: 3005180920-2021-00230
• Device Sequence Number: 17335182
• Product Code: LZO
• UDI-Device Identifier: 07630030809255
• UDI-Public: 07630030809255
• 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: 2021
• Device Explanted Year: 2021
• 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): 03/24/2021

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: 07/27/2025
• Device Model Number: 01.29.214
• Device Catalogue Number: 01.29.214
• Device Lot Number: 2004419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/24/2021
• 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
• Patient Age: 75 YR