MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER HEAD BIOLOX OPTION Ø 36; CERAMIC BALL HEAD

Catalog Number	01.29.232H
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the second revision surgery underwent by the patient.She had primary surgery in 2011.On (b)(6) 2016 the patient was revised due to pain caused by acetabular screw protruding posteriorly into soft tissue.The stem has remained as the only constant throughout the procedures.On 30 june 2017 the medical affairs performed a clinical evaluation and commented as follows: acetabular component re-revision surgery occurred 1 year after revision in a (b)(6) year old woman.The revised cup, which originated the problem, is not a medacta product.A medacta head was revised only because it is customary and appropriate, when an acetabular component is substituted, to replace the head with a new one.According to the report, the patient was complaining about pain.Radiographic images provided, show the presence of a screw protruding posteriorly in the pelvic soft tissues that can be the cause of pain.There is no reason to suspect a faulty medacta device.Batch reviews performed on 11 july 2017.Lot 131061: (b)(4) items manufactured and released on 01 march 2013.Expiration date: 2018-01-31.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 this lot.Mectacer sleeve size s, code 01.29.240a, lot.142165 (k131518) (b)(4) items manufactured and released on 15 january 2015.Expiration date : 2019-10-31.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.Quadra-h, cementless ha coated stem size 4 std (k082792) (b)(4) items manufactured and released on 17 june 2011.Expiration date : 2016-04-30.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
The patient had 3 dislocations and the surgeon decided to revise the acetabular component.

• Brand Name: MECTACER HEAD BIOLOX OPTION Ø 36
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6714018
• Report Number: 3005180920-2017-00378
• Device Sequence Number: 1247488
• Product Code: LZO
• UDI-Device Identifier: 07630030809347
• UDI-Public: 07630030809347
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131518
• 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): 07/14/2017

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: 01/31/2018
• Device Catalogue Number: 01.29.232H
• Device Lot Number: 131061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/14/2017
• 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