MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 32 SIZE S -3.5

Model Number	01.25.021
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 20 november 2020: lot 188824: (b)(4) items manufactured and released on 7-mar-2019.Expiration date: 2024-02-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other device involved in the event: liner: mpact 01.32.3241hct flat pe hc liner ¿32/d lot.1902883 (k103721), batch review performed by medacta regulatory affairs department on 20 november 2020: lot 1902883: (b)(4) items manufactured and released on 8-may-2019.Expiration date: 2024-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been 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 4 days after the primary surgery.The cause of the dislocation is unknown.The surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 32 SIZE S -3.5
• Common Device Name: BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10928298
• Report Number: 3005180920-2020-00872
• Device Sequence Number: 791291
• Product Code: JDI
• UDI-Device Identifier: 07630030805158
• UDI-Public: 07630030805158
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: 01.25.021
• Device Catalogue Number: 01.25.021
• Device Lot Number: 188824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2020
• Initial Report FDA Received Date: 12/01/2020
• 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
• Patient Age: 70 YR