MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM SIZE 6 LEFT

Catalog Number	01.13.106L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 november 2017.Lot 156589: (b)(4) items manufactured and released on 04 april 2016.Expiration date: 2021-03-21.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.On 13 november 2017 the cleaning and packaging manager performed a preliminary investigation based on the available picture and commented as follows: from the attached picture it was concluded that the failure was 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.A new packaging has been developed: it contains a tip securing the component that locks in place and can be positioned as appropriate to confidently secure all the stem lengths.
Event or Problem Description
During the stem implantation, the surgeon noticed that the device's primary packaging was damaged, it presented an hole.The surgeon removed the stem from the femur and waited the arrival of the back-up implant transported in urgency from the medacta (b)(4) warehouse.This event caused a critical delay in the surgery that was anyway completed successfully.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM SIZE 6 LEFT
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7040109
• Report Number: 3005180920-2017-00679
• Device Sequence Number: 1159077
• Product Code: LZO
• UDI-Device Identifier: 07630030803253
• UDI-Public: 07630030803253
• 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
• Report Date (Section B): 11/17/2017

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: 03/21/2021
• Device Catalogue Number: 01.13.106L
• Device Lot Number: 156589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• 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
• Patient Weight: 70