MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX FEMORAL CEMENTLESS STEM

Catalog Number	01.13.108R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 december 2017: lot 141946: (b)(4) items manufactured and released on 20 june 2014; expiration date: 2019-05-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold with 1 other similar reported event.
Event or Problem Description
The stem distal tip was found out of the foam causing the primary blister breakage.A second implant was used in order to complete the surgery.
Additional Manufacturer Narrative
Visual inspection performed by washing and packaging manager on 27 february 2018.The packaging is scratched.It was concluded that the damage 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 stems length as they allow more degrees of freedom for movement within the package.

• Brand Name: MINIMAX FEMORAL CEMENTLESS STEM
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142980
• Report Number: 3005180920-2017-00776
• Device Sequence Number: 10997869
• Product Code: LZO
• UDI-Device Identifier: 07630030803307
• UDI-Public: 07630030803307
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170845
• 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,Followup
• Report Date (Section B): 03/28/2018

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: 05/31/2019
• Device Catalogue Number: 01.13.108R
• Device Lot Number: 141946
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2017
• Supplement Date Received by Manufacturer: 11/25/2017
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/28/2018
• 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: 64 YR
• Patient Weight: 95