MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø32/C; FLAT LINER

Catalog Number	01.32.3239HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 23 february 2018 partial revision of tha after 2 days in a patient who had already been revised and had gone through infection.The spacer previously implanted had also dislocated severely; from this evidence we can assume that the status of muscles and restraining soft tissues in this hip was already seriously compromised.There is no reason to suspect that the components manufactured by medacta implanted to this patient had any problem.Batch review performed on 26 february 2018 lot 166655: (b)(4) items manufactured and released on 23 november 2016 expiration date: 2021-11-13.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.Mectacer biolox delta ceramic ball head 12/14 ø 32 size s -4 reference 01.29.204 (k112115): lot 174695: (b)(4) items manufactured and released on 20 september 2017.Expiration date: 2022-09-12 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.On 26 february 2018 medacta informed the manufacturer of the ceramic ball head.On 01 march 2018 they provided the requested document review, reporting as follows: protocols and certificate of conformance were reviewed.The quality documents show that the values obtained on the ball head were according to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing material defect.
Event or Problem Description
The patient had a primary with another company's product.The patient was infected and had a spacer implanted.On (b)(6) 2018 the surgeon implanted medacta products and two days after implantation the patient came in complaining of pain due to dislocation.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: FLAT LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7309117
• Report Number: 3005180920-2018-00109
• Device Sequence Number: 13765759
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 11/13/2021
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 166655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• 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: 54 YR