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

Catalog Number	02.07.F11030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 march 2019 by regulatory affairs department: 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.Preliminary investigation performed by washing and packaging manager: through a documental review it is possible to confirm that screws and screw bags (peel pouch) have been collected correctly.The operators involved in the lot have been interviewed and no anomaly has been discovered considering procedure and method.In spite of that, the process flow has been improved: now, the operator that collect the screws is not the same of who packs the screw in the bag.The lot 178687 has been packed following the old procedure (il 07.35 rev.9) unfortunately, in this specific case we did not receive the external packaging, the screw bag seems was not present, and we cannot establish if it was damaged, also, no additional conclusion can be drawn.
Event or Problem Description
The fixation screw, its packaging as well, was missing in the primary extension stem packaging.A back-up implant, different lot, has been opened in order to complete the surgery.
Additional Manufacturer Narrative
On march 27, 2019 we received back the primary extension stem that needed to be opened to take the screw that was missing in the package of the involved primary extension stem.No visual inspection needed as the received device was not directly involved in the issue.

• Brand Name: GMK-SPHERE PRIMARY EXTENSION STEM Ø11MM / L 30 MM
• Common Device Name: KNEE PRIMARY EXTENSION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8403890
• Report Number: 3005180920-2019-00128
• Device Sequence Number: 269063
• Product Code: JWH
• UDI-Device Identifier: 07630030822643
• UDI-Public: 07630030822643
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2023
• Device Catalogue Number: 02.07.F11030
• Device Lot Number: 178687
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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