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

Catalog Number	01.32.162DH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 july 2018: lot 166613: (b)(4) items manufactured and released on 02 february 2017.Expiration date: 2022-01-25.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.Batch review for the associated instrument performed on 30 july 2018: cup impactor ref.01.15.10.0294, lot.1752029: (b)(4) items manufactured and released on 08 june 2017.No anomalies found related to the problem.To date, this is the first similar event reported on items of the same lot.
Event or Problem Description
During a total hip when the surgeon was implanting the cup, the inserter disengaged from the cup.The surgeon used a secondary cup and a different inserter to complete the surgery.There was a ten minute delay in the case.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed (b)(6) 2018 by r&d product manager.The cup impactor was analyzed together with the shell.The instrument appeared without any visible damage; it was tried with mpact shells providing the correct locking of the implant.Vice versa, with the received implant, the impactor did not properly connect: the inner part of the shell was visibly damaged together with the inner thread.From the received pieces it is possible to determine that the instrument was not properly connected to the cup (maybe not correctly aligning the two parts) during the surgery that provided to a damaging of the inner thread of the implant and to the conseguent impossibility of connection.

• Brand Name: MPACT 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: 7731843
• Report Number: 3005180920-2018-00575
• Device Sequence Number: 19020599
• Product Code: LPH
• UDI-Device Identifier: 07630030810978
• UDI-Public: 07630030810978
• 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,Followup
• Report Date (Section B): 08/30/2018

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: 01/25/2022
• Device Catalogue Number: 01.32.162DH
• Device Lot Number: 166613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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