MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 28 SIZE XL +7

Model Number	01.25.014
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 6 november 2020: lot 080760: 50 items manufactured and released on 13-nov-2008.Expiration date: 2013-09-31.No anomalies found related to the problem.To date, 32 items of the same lot have been already sold without any similar reported event since 2016.Other devices involved in the event cup: versafitcup 01.26.54mb acetabular shell cc ø 54 lot.082537 (k083116) batch review performed on 6 november 2020: lot 082537: 8 items manufactured and released on 11-dic-2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any similar reported event since 2016.Liner: versafitcup dm 01.26.2854m double mobility liner ø 54/28 lot.082980 (k083116) batch review performed on 6 november 2020: lot 082980: 24 items manufactured and released on 09-dic-2008.Expiration date: 2013-10-31.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event since 2016.
Event or Problem Description
The patient came in after 11 years and 3 months from the primary surgery reporting pain and the cause of the pain is unknown.The surgeon revised the cup, liner, and head.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 28 SIZE XL +7
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10895757
• Report Number: 3005180920-2020-00828
• Device Sequence Number: 11570309
• Product Code: JDI
• UDI-Device Identifier: 07630030805134
• UDI-Public: 07630030805134
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 01.25.014
• Device Catalogue Number: 01.25.014
• Device Lot Number: 080760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/24/2020
• 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