MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0

Model Number	01.25.012
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 august 2020.Lot 177197: (b)(4) items manufactured and released on 01-feb-2018.Expiration date: 2023-01-24.No anomalies found related to the problem.To date, 128 items of the same lot have been already sold without any other similar reported event.Additional item involved in the event, batch review performed on 04 august 2020.Ball heads: bipolar head 25060.2850 bipolar head ø28x50 (k091967) lot.167637.Lot 167637: (b)(4) items manufactured and released on 08-mar-2017.Expiration date: 2022-02-13.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any other similar reported event.No manufacturing issue has been detected analyzing the documents received from the manufacturer.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the ball head from bipolar head.The cause of the dislocation is unknown, it happened 2 years and 2 months after primary.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10459904
• Report Number: 3005180920-2020-00548
• Device Sequence Number: 2199257
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 01/24/2023
• Device Model Number: 01.25.012
• Device Catalogue Number: 01.25.012
• Device Lot Number: 177197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/27/2020
• 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