MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø46 MULTI-HOLE; UNCEMENTED HIP SHELL

Catalog Number	01.32.146MH
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 june 2019: lot 155998: (b)(4) items manufactured and released on 22 march 2016.Expiration date: 2021-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Coating supplier manufacturing process review: the tigrowth-v is a coating that always presents some particle loss due to the high roughness of the coating.This case is similar to those reported in 2018, and in all cases the pieces date back to 2016 if not earlier.The piece in question was manufactured on in 2016, when the automated version was already active.After the previous reports we have implemented an additional final check on the pieces produced in vps, which is currently performed by a manager of the technical office or quality assurance in order to assess the particle loss of the pieces.Preliminary investigation performed by hip r&d project manager: tigrowth-v is a coating that always presents 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 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.Visual inspection performed by hip r&d project manager: from the received pieces, it is confirmed what written in the preliminary investigation; few small parts of the coating of the shell are 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
The surgeon discovered debris of the coating in the inner blister before implanting the mpact cup.It was doubtful if they were generated from titanium coating, so in order to avoid any risk, a back up mpact cup 48mm was used for the alternative.No critical delay.No patient related this event.

• Brand Name: MPACT ACETABULAR SHELL Ø46 MULTI-HOLE
• Common Device Name: UNCEMENTED HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8743235
• Report Number: 3005180920-2019-00518
• Device Sequence Number: 11189588
• Product Code: LPH
• UDI-Device Identifier: 07630030810718
• UDI-Public: 07630030810718
• 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): 06/28/2019

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: 03/09/2021
• Device Catalogue Number: 01.32.146MH
• Device Lot Number: 155998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/28/2019
• 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