MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES; HIP SHELL

Catalog Number	01.32.148DH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 1810283: (b)(4) items manufactured and released on 02 april 2019.Expiration date: 2024-03-20.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d hip project manager.During the analysis it is evaluated that the threaded part of the terminal is scratched and in addition also the threaded of the cup has some scratches.We have functionally evaluated the screw of the cup with the terminal evaluating that the connection is blocked during screwing phase.Probably the user impacted the cup before complete the screwing phase and this damaged the thread.The instrument is ce marked by supplier.
Event or Problem Description
The surgeon was not able to engage the mpact cup with the cup impactor correctly (not straight).The surgeon engaged the thread part of the instrument with the implant and tried to impact, but he was not able to set the mpact cup correctly.The surgeon used a bigger cup (same size cup not available) and a new cup impactor completing successfully the surgery.The event caused 30 minutes of delay in the surgery.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
• Common Device Name: HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8739673
• Report Number: 3005180920-2019-00512
• Device Sequence Number: 19230227
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 03/20/2024
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 1810283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/27/2019
• 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: Other