MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2

Catalog Number	01.13.102L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 19 december 2017.Lot 154899: (b)(4) items manufactured and released on 03 mar 2016.Expiration date: 2021-02-16 no anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold.Minimax cementless anatomical stem left size 2 reference 01.13.102l (k170845) lot 135068: (b)(4) items manufactured and released on 11 dec 2013.Expiration date: 2018-10-31 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.
Event or Problem Description
During surgery surgeon opened a first packaging and found the stem not in place and the broken blister.The surgeon opened a second packaging and he found that the stem was not in the correct position and he found scratches on the blister.The surgeon used the second stem available in the room since he did not have other back-up.Surgery completed successfully.
Additional Manufacturer Narrative
Packaging received for investigation.Visual inspection performed on (b)(6) 2018 by washing and packaging manager: 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 CEMENTLESS ANATOMICAL STEM LEFT SIZE 2
• Common Device Name: CEMENTLESS ANATOMICAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7129081
• Report Number: 3005180920-2017-00755
• Device Sequence Number: 13785051
• Product Code: LZO
• UDI-Device Identifier: 07630030803178
• UDI-Public: 07630030803178
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2021
• Device Catalogue Number: 01.13.102L
• Device Lot Number: 154899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2017
• Supplement Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 12/19/2017
• 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: 82 YR
• Patient Weight: 100