MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 7; CEMENTLESS HIP STEM

Catalog Number	01.18.137
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 february 2018 (b)(4).Inspection performed by washing and packaging manager on 19 february 2018: from the inspection of the pictures received it is possible confirmed the presence of evident scratches on the inner blister; it was concluded that the failure evidently occurred due to forces experienced during transportation.This was indicated to be correlated to the packaging configuration.
Event or Problem Description
When the or technician opened the implant noticed that the inner packaging was damaged.The box and wrapping remained undamaged.The surgeon used a secondary implant of the same size completing successfully and without delay the surgery.
Additional Manufacturer Narrative
Analysis performed on 21.February.2018 by packaging and washing process 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 also to the combination of the packaging configuration applied.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7281910
• Report Number: 3005180920-2018-00069
• Device Sequence Number: 13932655
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2016
• Device Catalogue Number: 01.18.137
• Device Lot Number: 156237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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
• Patient Age: 58 YR