MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5; HIP METALLIC FEMORAL HEAD

Catalog Number	01.25.013
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 september 2019: lot 112894: (b)(4) items manufactured and released on 30-aug-2011.Expiration date: 2017-07-31.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.Clinical evaluation performed by medacta medical affairs manager: recurring dislocation in tha.Serious lack of information prevents a full analysis to be performed.The radiographs supplied are not dated, so following the patient history is not possible.In one image, the cup looks rather vertical, but we couldn't determine if this is a projection effect or a migration from one postoperative position.No information is supplied as to patient activity, weight, age, or any other supplementary piece of information.The cause of this adverse could not be determined through the clinical investigation, but it's very unlike that it could be attributed to an implant malfunction.
Event or Problem Description
Revision surgery performed after 6 years from the previous revision surgery (performed in 2013 exact date unknown), due to luxation of the head form the cup liner (the liner involved is not marketed in the usa).The surgeon revised the head and the liner.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5
• Common Device Name: HIP METALLIC FEMORAL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9122743
• Report Number: 3005180920-2019-00796
• Device Sequence Number: 2830853
• Product Code: JDI
• UDI-Device Identifier: 07630030805127
• UDI-Public: 07630030805127
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 01.25.013
• Device Lot Number: 100919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/26/2019
• 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