MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT HOODED PE HC FIXED 32 / F; HIP SHELL LINER

Model Number	01.26.3248HCAT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2020: lot 102330: (b)(4) items manufactured and released on 26-aug-2010.Expiration date: 2015-07-31.No anomalies found related to the problem since 2016.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: 9 years after primary cementless tha the patient suffers a dislocation and therefore the cup is replaced to a dual mobility system.A possible cause for the event is increased lumbar stiffness, coupled with a cup that had little anteversion.No reason to suspect a defective device.
Event or Problem Description
The patient had been complaining of instability after an incident of bending over and lifting something.The surgeon then revised head and liner (8 years and 7 months after primary surgery) in order to implant a dual mobility system.
Additional Manufacturer Narrative
The revised ceramic hip head is not marketed in the usa.Anyway the ball head supplier reports about the ball head lot: 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 tha quality documents fulfil the requirements as specified at the time of production.There are no indications of any pre-existing maerial defect.Due to a lack of ceramic parts further investigations cannot be done.

• Brand Name: LINER: CC E CC LIGHT HOODED PE HC FIXED 32 / F
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10008594
• Report Number: 3005180920-2020-00264
• Device Sequence Number: 2897706
• Product Code: LZO
• UDI-Device Identifier: 07630030807602
• UDI-Public: 07630030807602
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 07/31/2015
• Device Model Number: 01.26.3248HCAT
• Device Catalogue Number: 01.26.3248HCAT
• Device Lot Number: 102330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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: 75 YR
• Patient Weight: 80