MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R; FEMORAL COMPONENT CEMENTED

Catalog Number	02.12.0002R
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 154704: 41 items manufactured and released on (b)(6) 2015.Expiration date: (b)(6) 2020.No anomalies found related to the problem.To date, 35 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by vice technical director on (b)(6) 2018.The inner packaging is confirmed to be broken, as it could be seen also from the pictures provided at the moment of the notification.It is the first time that this failure is observed on this implant.It is likely that the implant has been manipulated in the wrong way or dropped.
Event or Problem Description
When the femoral component was opened, it was noticed that the internal packaging was cracked.The surgeon used a secondary implant completing successfully the surgery.
Additional Manufacturer Narrative
Visual inspection performed on the 28 september 2018 by medacta washing & packaging manager.After the inspection of the received packaging i confirm what reported in the preliminary investigation.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7897540
• Report Number: 3005180920-2018-00714
• Device Sequence Number: 19180957
• Product Code: JWH
• UDI-Device Identifier: 07630030825804
• UDI-Public: 07630030825804
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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): 10/17/2018

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: 10/05/2020
• Device Catalogue Number: 02.12.0002R
• Device Lot Number: 154704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/17/2018
• 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