MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M; HIP CERAMIC BALL HEAD

Model Number	01.29.213
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2022.Lot 2007651: (b)(4) items manufactured and released on 27-oct-2020.Expiration date: 2025-10-14.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.Additional component involved: batch review performed on 18 may 2022.Liner: impact 01.32.4048hct flat pe hc liner 40/f (k122641) lot 2013107: (b)(4) items manufactured and released on 29-jan-2021.Expiration date: 2026-01-06.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
The patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head 1 year after primary.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER 01.29.213 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14698597
• Report Number: 3005180920-2022-00452
• Device Sequence Number: 5175130
• Product Code: LZO
• UDI-Device Identifier: 07630030809248
• UDI-Public: 07630030809248
• 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: 2022
• 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): 06/15/2022

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: 10/14/2025
• Device Model Number: 01.29.213
• Device Catalogue Number: 01.29.213
• Device Lot Number: 2007651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2020
• 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 Sex: Male