MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0; COCR FEMORAL HEAD

Catalog Number	01.25.022
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 november 2018.Lot 165651: (b)(4) items manufactured and released on 01 february 2017.Expiration date: 2022-01-24.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.Additional component revised: liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e, lot 172573: (b)(4) items; manufactured and released on 05 september 2017.Expiration date: 2022-08-23.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
About 10 months after primary the surgeon revised the patient for an infection case.The patient had already undergone to two washout before detecting the infection.The pathogen was found to be staphylococcus aureus.Liner and head swap was performed.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0
• Common Device Name: COCR FEMORAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8064114
• Report Number: 3005180920-2018-00882
• Device Sequence Number: 11249455
• Product Code: JDI
• UDI-Device Identifier: 07630030805165
• UDI-Public: 07630030805165
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: 01/24/2022
• Device Catalogue Number: 01.25.022
• Device Lot Number: 165651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 11/13/2018
• 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: 64 YR
• Patient Weight: 95