MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 36 SIZE M 0; METAL BALL HEAD

Model Number	01.25.031
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15.November.2021: lot 2104424: (b)(4) items manufactured and released on 12-07-2021.Expiration date: 2026-06-22 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events.Additional implant involved: liner: mpact 01.32.3652hct flat pe hc liner ø36/g (k103721) lot.2100163.Batch review performed on 15.November.2021: lot 2100163: (b)(4) items manufactured and released on 1-feb-2021.Expiration date: 2026-01-19.No anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events.
Event or Problem Description
The patient came in 3 days after the primary surgery reporting pain due to a dislocation of the head from the liner.The surgeon revised the cup, head, and liner.The surgery was completed successfully.The surgeon implanted a larger dm cup with more anteversion put in.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 36 SIZE M 0
• Common Device Name: METAL 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: 12890288
• Report Number: 3005180920-2021-00961
• Device Sequence Number: 1521285
• Product Code: JDI
• UDI-Device Identifier: 07630030805219
• UDI-Public: 07630030805219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/30/2021

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: 06/22/2026
• Device Model Number: 01.25.031
• Device Catalogue Number: 01.25.031
• Device Lot Number: 2104424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2021
• 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