MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR 01.25.011 COCR BALL HEAD 12/14 28 SIZE S -3.5; HIP BALL HEAD

Model Number	01.25.011
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 august 2021: lot 2010461: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2025-dec-29.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 devices involved: batch review performed on 18 august 2021: versafitcup dm 01.26.2854mhc double mobility hc liner 28/dmg (k092265) lot 2100184: (b)(4) items manufactured and released on 18-march-2021.Expiration date: 2026-march-04.No anomalies found related to the problem.To date, 94 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 and the cause is unknown.1 month after the primary surgery, the surgeon revised all components and the surgery was completed successfully.

• Brand Name: COCR 01.25.011 COCR BALL HEAD 12/14 28 SIZE S -3.5
• Common Device Name: HIP BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12475408
• Report Number: 3005180920-2021-00741
• Device Sequence Number: 3939468
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• 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: 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): 09/15/2021

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: 12/29/2025
• Device Model Number: 01.25.011
• Device Catalogue Number: 01.25.011
• Device Lot Number: 2010461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/15/2021
• 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