MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 32 SIZE M 0; HIP COCR BALL HEAD

Model Number	01.25.022
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 august 2020: lot 090209: (b)(4) items manufactured and released on 16-apr-2009.Expiration date: 2014-03-31.No anomalies found related to the problem.To date all the items of the same lot have been already sold without any similar reported event since 2016.Additional device involved: batch review performed on 29 july 2020: liner: versafitcup cc trio 01.26.3248hct flat pe hc liner ø 32 / f (k103352) lot 111547: (b)(4) items manufactured and released on 13-jul-2011.Expiration date: 2016-06-30.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 a dislocation of the hip metallic ball head from the liner.7 years and 11 months after primary the surgeon revised the cup and liner and the surgery was completed successfully.The metallic head was left in place.

• Brand Name: COCR BALL HEAD 12/14 32 SIZE M 0
• Common Device Name: HIP COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10425795
• Report Number: 3005180920-2020-00521
• Device Sequence Number: 14093723
• Product Code: JDI
• UDI-Device Identifier: 07630030805165
• UDI-Public: 07630030805165
• 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: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 03/31/2014
• Device Model Number: 01.25.022
• Device Catalogue Number: 01.25.022
• Device Lot Number: 090209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/19/2020
• 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