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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/12/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00912
• Device Sequence Number: 12069513
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2022

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male