MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28; HIP SHELL LINER

Model Number 01.26.2850MHC

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 11/12/2022

Event Type  Injury  

Event Description

The patient has a primary hip surgery on (b)(6) 2010.The surgeon used another company's head and stem with medacta cup and liner.The patient was revised on (b)(6) 2016.The patient came in complaining of instability.The surgeon noticed the stem had subsided.The surgeon revised the other company's product along with the medacta poly.The cup remained in place.The surgery was completed successfully.On (b)(6) 2022, the patient had a spinal fusion surgery and soon after starting feeling pain in the hip.When the surgeon evaluated the patient, it was noted that the hip became unstable after the spinal fusion surgery.The surgeon revised the cup, head, and liner with competitor components.The surgery was completed successfully.The liner was found broken.

Manufacturer Narrative

Batch review performed on (b)(6) 2022: lot 156461: (b)(4) items manufactured and released on 10-feb-2016.Expiration date: 2021-01-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Preliminary analysis performed by r&d project manager: the liner has been found completely damaged with a hole on the central part.The head has been found scratched, in a rather uniform fashion, almost all over the entire articulating surface.This is compatible with one or multiple hard bodies of small dimensions that were possibly trapped in the articulation causing the polyethylene wear.The patient underwent revision surgery in 2016 when maybe one or multiple hard bodies interposed between the head and the liner.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28
• Type of Device: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15969322
• MDR Text Key: 305350646
• Report Number: 3005180920-2022-00912
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 01.26.2850MHC
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 156461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male