MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø58 MULTI-HOLE

Catalog Number	01.32.158MH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 january 2019.Lot 153879 : (b)(6) items manufactured and released on 29 february 2016.Expiration date: 2021-01-26.No anomalies found related to the problem.To date, 11 items of the same lot have been already sold without any similar reported event.Investigation performed by coating supplier: the particle loss is associated with a final finishing not properly performed; but also, since the tigrowh-v is a very porous and wrinkled coating, it can not be completely avoided.Moreover, packaging and the continuous movement of the piece inside the blister during shipment, accentuates this phenomenon.Based on the fact that the implant was anyway implanted, probably the surgeon has considered the episode as non-critical.The manufacturer has improved the production controls such as check of the boxes before shipment.Preliminary investigation performed by r&d product manager: the image was analyzed.From the received image it is not possible to determine the root cause of the event; the event could be related to different phenomena, like the typology of the coating, which is highly wrinkled, the packaging and eventual movements of the piece inside the blister during the shipment.
Event or Problem Description
During the primary hip surgery and upon opening the cup packaging, it was discovered that there was foreign debris inside the packaging.There was a 10 minute delay in the case while the agent checked his inventory to see if there was another cup available.No other cup was available so the surgeon cleaned the debris off of the cup and implanted it into the patient.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø58 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8277371
• Report Number: 3005180920-2019-00004
• Device Sequence Number: 1617107
• Product Code: LPH
• UDI-Device Identifier: 07630030810909
• UDI-Public: 07630030810909
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 01/25/2019

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: 01/26/2021
• Device Catalogue Number: 01.32.158MH
• Device Lot Number: 153879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/25/2019
• 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