MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 7; CEMENTED HIP STEM

Catalog Number	01.18.157
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 june 2018; lot 144501:(b)(4) items manufactured and released on 01 september 2014.Expiration date: 2019-06-30; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed on 21 june 2018; after the visual inspection, it was concluded that the damage evidently occurred due to forces experienced during transportation/handling.This was indicated to be correlated to the packaging configuration that allows degrees of freedom for movement within the package.In february 2017 modification of the packaging, 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
The packaging was found broken, with plastic debris on the prosthesis.The stem was not used.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 7
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7629558
• Report Number: 3005180920-2018-00455
• Device Sequence Number: 2143705
• Product Code: LZO
• UDI-Device Identifier: 07630030804328
• UDI-Public: 07630030804328
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103189
• 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): 06/22/2018

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: 01.18.157
• Device Lot Number: 144501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: 77 YR