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

Model Number	01.25.014
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 december 2020.Lot 114020: 60 items manufactured and released on 9-jan-2012.Expiration date: 2016-11-30.No anomalies found related to the problem.To date, 53 items of the same lot have been sold without any other similar reported event since 2016.Additional implant involved: liner: versafitcup dm 01.26.2854mhc double mobility hc liner ø 54/28 (k092265) lot.115087.Batch review performed on (b)(6) 2020.Lot 115087: 42 items manufactured and released on 7-mar-2012.Expiration date: 2017-01-31.No anomalies found related to the problem.To date, 41 items of the same lot have been sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in after 8 years and 6 months from the primary surgery reporting pain and was diagnosed with trunnionosis(the cause in unknown).The surgeon revised the head and liner and the surgery was completed successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE XL +7
• Common Device Name: METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11153622
• Report Number: 3005180920-2021-00037
• Device Sequence Number: 3344223
• Product Code: JDI
• UDI-Device Identifier: 07630030805134
• UDI-Public: 07630030805134
• Combination Product (Y/N): N
• 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: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 11/30/2016
• Device Model Number: 01.25.014
• Device Catalogue Number: 01.25.014
• Device Lot Number: 114020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 01/12/2021
• 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
• Patient Age: 76 YR