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

Catalog Number	01.25.023
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.On (b)(6) 2017 the patient had a revision of non-medacta products due to infection.On 21 july 2017 the medical affairs performed a clinical evaluation based on the available pictures and commented as follows: hip dislocation few months after revision hip arthroplasty following infection.A new head, in the final operation, two sizes longer than the previous one was used to restore soft tissue tension and possibly leg length.This may be the consequence of stem subsidence (a possible sequela after infection) or for insufficient tension achieved during the first revision surgery: the former images are not available.There is no reason to suspect a faulty device.Batch reviews performed on 25 july 2017.Lot 152724: (b)(4) items manufactured and released on 30 october 2015.Expiration date: 2020-10-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on items of the same lot.Versafitcup flat pe hc liner ø 32 / f, code 01.26.3248hct, lot.164467 (k103352) (b)(4) items manufactured and released on 05 october 2016.Expiration date: 2021-09-22.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 due to hip luxation.Head and liner were explanted.No trauma was reported.

• Brand Name: COCR BALL HEAD 12/14 Ø 32 SIZE L +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: 6740185
• Report Number: 3005180920-2017-00406
• Device Sequence Number: 19025586
• Product Code: JDI
• UDI-Device Identifier: 07630030805172
• UDI-Public: 07630030805172
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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: 10/11/2020
• Device Catalogue Number: 01.25.023
• Device Lot Number: 152724
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/25/2017
• 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: 67 YR