MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 00; CEMENTLESS HIP STEM

Catalog Number	01.18.098
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 april 2018: lot 144461: (b)(4) items manufactured and released on 29 august 2014.Expiration date: 2019-06-30.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.Visual inspection performed on 18.April.2018 by washing and packaging manager: from the visual inspection it was concluded that the issue evidently occurred due to forces experienced during transportation.This was indicated to be correlated to the combination of the packaging configuration applied and the shorter length stems as they allow more degrees of freedom for movement within the package.During the visual inspection also the photos attached were considered.
Event or Problem Description
When the stem was opened it was noticed that the hard plastic was damaged.The external box was intact.The surgeon used a secondary stem to complete the surgery.There was no delay in the case.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE 00
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7442490
• Report Number: 3005180920-2018-00241
• Device Sequence Number: 11044048
• Product Code: LZO
• UDI-Device Identifier: 07630030803765
• UDI-Public: 07630030803765
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 06/30/2019
• Device Catalogue Number: 01.18.098
• Device Lot Number: 144461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/19/2018
• 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