MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø62; ACETABULAR CUP

Catalog Number	01.32.162MB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 july 2019: lot 160901: (b)(4) items manufactured and released on 18-may-2016.Expiration date: 2021-05-02.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.Coating external supplier analysis: thank you for the report, which was recorded in our quality system.We are sorry that this problem has been reported again, but as you well know, the tigrowth-v is a coating that always presents a minimum particle loss due to the high roughness of the coating.This episode is however similar to those reported in 2018, and in all cases the pieces date back to 2016 if not earlier.The piece in question was worked on in 2016, when the automated post processing version was already active.I would like to inform you that after the previous reports we have implemented an additional final check on the pieces produced in vps in order to evaluate the particle loss of the pieces.For the specific episode we don't need to have the device in view.Preliminary investigation performed by r&d project manager: from the reviewed pieces it is possible that few small parts of the coating of the shell separated: the episode occurred on an old lot, probably due to high compliance between shell and blister and after shocks between the part and the packaging.On recent lots, it was implemented an additional final check on the pieces produced in vps in order to assess the particle loss of the pieces.
Event or Problem Description
During the primary hip surgery and upon opening the cup, the surgeon observed coating debris in the packaging.The surgery was completed successfully using a back-up cup.The implant was in a loaner kit.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the tigrowth-v is a coating that can present a minimum particle loss due to the high roughness of the coating.This is a non frequent episode, occurred on an old lot, probably due to high compliance between shell and blister and after some shocks between the part and the packaging.On recent lots, it was implemented an additional final check on the pieces produced in vps in order to assess the particle loss of the pieces.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø62
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8845246
• Report Number: 3005180920-2019-00650
• Device Sequence Number: 19423461
• Product Code: LPH
• UDI-Device Identifier: 07630030861024
• UDI-Public: 07630030861024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2021
• Device Catalogue Number: 01.32.162MB
• Device Lot Number: 160901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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