MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5; HIP COCR HEAD

Catalog Number	01.25.011
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 177464 : (b)(4) items manufactured and released on 27 february 2018.Expiration date: 2023-02-15.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 implants involved ball heads: bipolar head 25060.2850 bipolar head ø28x50 lot.176898 (k091967): (b)(4) items manufactured and released on 01 march 2018.Expiration date: 2023-02-08.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 performed after 2 months from the primary due to pain caused by fractured acetabulum.Prior to the primary surgery, the patient had severe bone loss in her femoral head which in turn caused erosion of her acetabulum.The bipolar head under stress pushed through the acetabular wall.The surgeon revised bipolar head and the cocr head successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5
• Common Device Name: HIP COCR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8883103
• Report Number: 3005180920-2019-00683
• Device Sequence Number: 16778645
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• 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: 2019
• 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): 08/12/2019

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: 02/15/2023
• Device Catalogue Number: 01.25.011
• Device Lot Number: 177464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/12/2019
• 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