MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER 01.29.207 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL

Model Number	01.29.207
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2018.Subsequently, the patient came in reporting pain due to a dislocation of the head from the liner.On (b)(6) 2020, the surgeon revised the head and liner the surgery was completed successfully.On (b)(6) 2022, the patient came in reporting instability and the surgeon revised the head and utilized an option sleeve.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11may 2022: lot 163454: (b)(4) items manufactured and released on 04-oct-2016.Expiration date: 2021-09-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: MECTACER 01.29.207 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL
• Common Device Name: DELTA 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: 14588455
• Report Number: 3005180920-2022-00423
• Device Sequence Number: 13958460
• Product Code: LZO
• UDI-Device Identifier: 07630030809187
• UDI-Public: 07630030809187
• 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: 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): 06/03/2022

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: 09/21/2021
• Device Model Number: 01.29.207
• Device Catalogue Number: 01.29.207
• Device Lot Number: 163454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2016
• 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: Female