MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L; HIP CERAMIC BALL HEAD

Model Number	01.29.203
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2021: lot 163448: 90 items manufactured and released on 28-oct-2016.Expiration date: 21-09-2021.No anomalies found related to the problem.To date, 78 items of the same lot have been sold without any reported event since 2017.Additional device involved: batch review performed on 02 july 2021: liner: mpact 01.32.2837hct flat pe hc liner ø28/b (k103721) lot 176961: 44 items manufactured and released on 1-mar-2018.Expiration date: 13-02-2023.No anomalies found related to the problem.To date, 30 items of the same lot have been sold without other reported event.
Event or Problem Description
1 year and 8 months after the primary surgery the patient came in reporting pain due to a dislocation of the head from the liner.The cause of the dislocation is unknown.The surgeon revised the medacta cup and liner with competitor implants and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12224562
• Report Number: 3005180920-2021-00613
• Device Sequence Number: 14562982
• Product Code: LZO
• UDI-Device Identifier: 07630030809149
• UDI-Public: 07630030809149
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 07/26/2021

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: 09/21/2021
• Device Model Number: 01.29.203
• Device Catalogue Number: 01.29.203
• Device Lot Number: 163448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/26/2021
• 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