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

Model Number	01.25.011
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 june 2020: lot 124250: (b)(4) items manufactured and released on 04-dec -2012.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Additional item involved in the event, batch review performed on 12 june 2020: liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot.124167.Lot 124167: (b)(4) items manufactured and released on 11-dec-2012.Expiration date: 2017-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.
Event or Problem Description
The patient came in reporting pain due to metallosis and a leg length discrepancy.The surgeon performed a washout and revised the head and liner, 7 years and 2 months after primary surgery.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE S -3.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10223037
• Report Number: 3005180920-2020-00368
• Device Sequence Number: 536102
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: 10/31/2017
• Device Model Number: 01.25.011
• Device Catalogue Number: 01.25.011
• Device Lot Number: 124250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/02/2020
• 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