MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY PRIMARY EXTENSION STEM Ø11MM / L 30 MM; KNEE EXTENSION STEM

Catalog Number	02.07.F11030
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 5 september 2019: lot 178687: (b)(4) items manufactured and released on 01-feb-2018.Expiration date: 2023-01-15.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 by washing and packaging manager: it is possible confirm that the primary packaging of the implant is broken.The component is out of its bag.It is probable that during the transportation or implant storage the stem broke the bag.The displacement possibly occurred due to forces experienced during transportation.
Event or Problem Description
During packaging opening the agent and the surgeon discovered that the paper bag of the extension stem was broken.The surgery was finished with a back-up implant.No critical delay experienced.

• Brand Name: GMK-PRIMARY PRIMARY EXTENSION STEM Ø11MM / L 30 MM
• Common Device Name: KNEE EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9114996
• Report Number: 3005180920-2019-00801
• Device Sequence Number: 19517863
• Product Code: JWH
• UDI-Device Identifier: 07630030822643
• UDI-Public: 07630030822643
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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: 01/15/2023
• Device Catalogue Number: 02.07.F11030
• Device Lot Number: 178687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/25/2019
• 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: 53