MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION EXTENSION STEM - FLUTED Ø 22 L 65; KNEE EXTENSION STEM

Catalog Number	02.07.FCL22065
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2017.Lot 145063: (b)(4) items manufactured and released on 29 october 2014.Expiration date: 2019-09-30.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.On 20 october 2017 the cleaning and packaging manager performed a visual inspection of the retrieved item and commented as follows: from the picture received from the field through the inspection of the retrieved item, it is possible confirm that the primary packaging of the implant is broken.The component is out of its foam.It is probable that during the transportation or implant storage the foam disassembled from the implant, the implant broke the plastic packaging due to the nature of the stem and because it was free to move.The displacement possibly occurred due to forces experienced during transportation.This is indicated to correlate to the combination of the packaging configuration applied and the geometry of the device that allow more degrees of freedom for movement within the package.
Event or Problem Description
During surgery when the stem was opened, it was notified that the packaging was damaged.The surgeon used a secondary implant for the case.The surgery was completed successfully.

• Brand Name: GMK-REVISION EXTENSION STEM - FLUTED Ø 22 L 65
• Common Device Name: KNEE EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6965050
• Report Number: 3005180920-2017-00599
• Device Sequence Number: 1297510
• Product Code: JWH
• UDI-Device Identifier: 07630030823114
• UDI-Public: 07630030823114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 09/30/2019
• Device Catalogue Number: 02.07.FCL22065
• Device Lot Number: 145063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/20/2017
• 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: 65 YR