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

Catalog Number	01.25.014
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 may 2018; lot 145715: (b)(4) items manufactured and released on 28 october 2014.Expiration date: 2019-09-30; 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; mpact dm double mobility hc liner 28/dmg reference 01.26.2854mhc (k092265); lot 174324: (b)(4) items manufactured and released on 22 november 2017.Expiration date: 2022-11-06; 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.
Event or Problem Description
Revision surgery due to signs of infection after 2 months.The pathogen is unknown.The surgeon revised the head and liner.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE XL +7
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7522290
• Report Number: 3005180920-2018-00338
• Device Sequence Number: 19188673
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 09/30/2019
• Device Catalogue Number: 01.25.014
• Device Lot Number: 145715
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• 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
• Patient Age: 55 YR