MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5

Catalog Number	01.25.124
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 december 2018 lot 122441b released on 08 march 2018.Expiration date: 2023-02-27.Totally, (b)(4) pieces produced.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.Other device involved: batch review performed on 14 december 2018 lot 174128: (b)(4) items manufactured and released on 21 december 2017.Expiration date: 2022-11-22.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in,1 months and 9 days after primary surgery, due to a dislocation of the head from the acetabulum, one month after primary surgery.The surgeon revised the bipolar head and implanted a 32mm cocr head, cup and liner.

• Brand Name: COCR BALL HEAD 12/14 Ø 22 SIZE S -2,5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8164778
• Report Number: 3005180920-2018-01003
• Device Sequence Number: 16830738
• Product Code: JDI
• UDI-Device Identifier: 07630030805486
• UDI-Public: 07630030805486
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K080885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 02/27/2023
• Device Catalogue Number: 01.25.124
• Device Lot Number: 122441B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/14/2018
• 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