MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 28 SIZE M 0; METALLIC BALL HEAD

Catalog Number	01.25.012
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Disorder (2373)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.Primary surgery took place on (b)(6) 2011.The patient dislocated twice (late 2011/early 2012), and on (b)(6) 2012 he/she was revised to a non-medatca, dm cup and a new longer medacta head.Then, the patient came in again and the surgeon booked another revision surgery since the joint had 'locked up' and the greater trochanter had fractured.On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: trochanteric fracture in a (b)(6) cementless tha, consisting of a medacta stem and another manufacturer's cup.According to report, the joint "locked up" and the abductor muscles broke the greater trochanter, weakened by the presence of the prosthetic stem.We do not know what caused the "locking up": the use of another company's cup had been decided because the patient had recurrent dislocations, therefore the original medacta cup was explanted and substituted with a double-mobility system available at the hospital.It is conceivable, albeit extremely unusual, that the hybrid coupling of two companies products may have contributed to the locking up, but as explants were discarded we cannot measure them and understand what happened.The cause of the stem revision is a trochanteric fracture; the cause of the lock up is unknown.Batch review performed on 28 august 2017.Lot 111572: (b)(4) items manufactured and released on 01 july 2011.Expiration date: 2016-05-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed due to limited range of motion and greater trochanter fracture.The fracture was treated with three trochanteric plates in order to fix it internally.The medacta head was replaced.The inlay was changed as well but it was anon- medacta product.The surgeon stated that no excessive signs of wear or debris were visible.

• Brand Name: COCR BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: METALLIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6837595
• Report Number: 3005180920-2017-00485
• Device Sequence Number: 13612305
• Product Code: JDI
• UDI-Device Identifier: 07630030805110
• UDI-Public: 07630030805110
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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: 05/31/2016
• Device Catalogue Number: 01.25.012
• Device Lot Number: 111572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/01/2017
• 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: 71 YR
• Patient Weight: 50