MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5; HIP METAL BALL HEAD

Catalog Number	01.25.023
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2019: lot 082621/t: (b)(4) items manufactured and released on 21-feb-2014.Expiration date: 2019-01-31.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 device involved: batch review performed on 10 july 2019: liner: mpact 01.32.3248hcat hooded pe hc liner ø32/f (k132879) lot 162916: (b)(4) items manufactured and released on 24-may-2016.Expiration date: 2021-05-05.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.
Event or Problem Description
The patient came in complaining of pain due to a dislocation of the head from the liner 2 years after primary.The surgeon revised the medacta cup and liner with another company's product and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: BALL HEADS: COCR COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5
• Common Device Name: HIP METAL BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8814970
• Report Number: 3005180920-2019-00595
• Device Sequence Number: 342843
• Product Code: JDI
• UDI-Device Identifier: 07630030805172
• UDI-Public: 07630030805172
• 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: 2017
• 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): 07/23/2019

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: 01/31/2019
• Device Catalogue Number: 01.25.023
• Device Lot Number: 082621/T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• 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