MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 8; CEMENTLESS STEM

Catalog Number	01.13.108L
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 february 2018.Lot 166128: (b)(4) items manufactured and released on 07 december 2016.Expiration date: 2021-11-28.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.Minimax cementless anatomical stem left size 8 reference (b)(4).Lot 100100: (b)(4) items manufactured and released on 26 mar 2010.Expiration date: 2015-02-28 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 30 january 2018 by packaging and washing manager: from the visual inspection the presence of evident scratches on the inner blister were confirmed; 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
During surgery the stem packaging was found damaged and broken (hole).A second stem of the same size was opened: the packaging was damaged, but in better condition compared to the previous one, so it was implanted.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 8
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7258659
• Report Number: 3005180920-2018-00029
• Device Sequence Number: 2117076
• Product Code: LZO
• UDI-Device Identifier: 07630030803291
• UDI-Public: 07630030803291
• 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): 02/09/2018

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: 11/28/2021
• Device Catalogue Number: 01.13.108L
• Device Lot Number: 166128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: 69 YR
• Patient Weight: 100