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

Catalog Number	01.25.011
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: a tha patient with recurrent dislocation was revised few days after primary surgery; a double mobility cup was implanted.This is normally a good solution for patient that show hip instability.The problem that originated revision surgery is not to be attributed to a faulty implant, it's usually due to lack or inefficiency of stabilizing anatomical structures on the patient side.Batch reviews performed on (b)(6) 2017.Lot 165886: (b)(4) items manufactured and released on 05 january 2017.Expiration date: 2021-12-19.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 flat pe hc liner ø28/b, code 01.32.2837hct, lot.160902 (k103721).(b)(4) items manufactured and released on 20 april 2016.Expiration date: 2021-04-03.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
The patient had dislocated twice since her primary surgery.Head, liner and cup were removed.Final reduction was achieved and provided good stability.The head dislocated from the liner.The revision surgery was completed successfully.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5
• Common Device Name: METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6921430
• Report Number: 3005180920-2017-00562
• Device Sequence Number: 13804777
• Product Code: JDI
• UDI-Device Identifier: 07630030805103
• UDI-Public: 07630030805103
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: 12/19/2021
• Device Catalogue Number: 01.25.011
• Device Lot Number: 165886
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/06/2017
• 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: 69 YR
• Patient Weight: 80