MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.18.144
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 16 october 2018.Lot 145427: (b)(4) items manufactured and released on 10 october 2014.Expiration date: 2016-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed by packaging and washing manager on october 15, 2018.On the basis of the pictures received it can be confirmed that the issue could have been 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.Modification was completed in february 2017, and the packaging produced from then contains a tip securing component that locks in place and can be positioned as appropriate to confidently secure all the stem lengths.
Event or Problem Description
Internal blister damaged (broken).The outer blister was not damaged.The surgery was completed successfully using another stem.
Additional Manufacturer Narrative
Visual inspection performed on november 14, 2018 by washing and packaging manager: the visual inspection confirmed the preliminary investigation performed on the attached photos.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7968807
• Report Number: 3005180920-2018-00791
• Device Sequence Number: 1681854
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• 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): 11/15/2018

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: 03/31/2016
• Device Catalogue Number: 01.18.144
• Device Lot Number: 145427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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