MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM ACETABULAR SHELL; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.162MB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) the coating supplier checked the batch documents without finding any technical anomaly related to the processes of both devices.On (b)(6) the r&d project managed analysed the images received, commenting: in all the images, particles of coating can be noted inside the packaging.Also the image relative to the internal blister shows evident damages and scratches.Problem of transportation can be a reasonable reason to explain the condition of both packaging and implant.Batch review performed on (b)(6) 2018: lot 160433: 19 items manufactured and released on (b)(6) 2016.Expiration date: 2021-04-12.No anomalies found related to the issue.To date, 1 item of the same lot has been already sold without any similar reported event.Mpact double mobility acetabular shell ø64 ref.01.32.164mb lot.162394 (k143453): the 15 items manufactured and released on (b)(6) 2016.Expiration date: 2021-07-05.No anomalies found related to the issue.To date, 1 item of the same lot has been already sold without any similar reported event.
Event or Problem Description
During surgery it was noticed that 2 implants had debris inside the packaging.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager on september 27, 2018: the particles of coating were well visible in the package, detached from the implant.The debris was present inside the blister, in which many scratches were visible due to the impingement between blister and debris.Moreover, the internal mousse was deformed and with a consistent presence of holes caused by debris.According to the preliminary inspection, a possible root cause can be related to a problem that occurred during the transportation.Coating manufacturer analysis received on october 01, 2018: packaging blister is evidently damaged, a possible root cause can be related to a problem that occurred during the transportation.

• Brand Name: MPACT DM ACETABULAR SHELL
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734865
• Report Number: 3005180920-2018-00557
• Device Sequence Number: 19525996
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: 04/12/2021
• Device Catalogue Number: 01.32.162MB
• Device Lot Number: 160433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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