MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 36 SIZE XXL +10.5

Catalog Number	01.25.034
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 october 2019 lot 112523: (b)(4) items manufactured and released on 18-sep-2011.Expiration date: 2016-08-31.No anomalies found related to the problem.1 item resterilized and released on 25-jul-2016.Expiration date: 2021-07-05.No anomalies found related to the problem.1 item resterilized and released on 11-nov-2016.Expiration date: 2021-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved in the event, batch review performed on 31 october 2019 liner: impact 01.32.3644 hcat hooded pe hc liner ø36/e (k132879) lot.145278.Lot 145278: (b)(4) items manufactured and released on 03-dec-2014.Expiration date: 2019-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Note that, in the first reported case on this lot, the liner was not revised and was the same patient where only the head was changed.
Event or Problem Description
The patient came in complaining of pain due to a dislocation of the head from the liner.The surgeon revised the head, liner, and cup 1 year after primary.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 36 SIZE XXL +10.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9361114
• Report Number: 3005180920-2019-00978
• Device Sequence Number: 2114658
• Product Code: JDI
• UDI-Device Identifier: 07630030805240
• UDI-Public: 07630030805240
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 08/31/2016
• Device Catalogue Number: 01.25.034
• Device Lot Number: 112523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/22/2019
• 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: 63 YR