MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE FEMUR; FIXED CEMENTED FEMORAL COMPONENT SIZE 2 LEFT

Catalog Number	02.12.0002L
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After several attempts last answer received on 27 july 2017,, we were not able to get details (product code and lot) about the trial femoral components used in the surgery.Batch review performed on 26 july 2017.Lot 163318: (b)(4) items manufactured and released on 26 july 2016.Expiration date: 2021-06-29.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.
Event or Problem Description
During a primary left knee case.After all cuts were made, the surgeon trialed with a femoral trial size 2l, when he moved from extension into flexion the femoral trial became unseated from the femur.The surgeon was unable to get the trail to seat back onto the femur.There was a delay of approximately 7 minutes.The surgeon opened the implant to trail with the implant.The implant was also loose.The surgeon cemented the implant into the patient.The surgery was completed successfully.

• Brand Name: GMK SPHERE FEMUR
• Common Device Name: FIXED CEMENTED FEMORAL COMPONENT SIZE 2 LEFT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6763298
• Report Number: 3005180920-2017-00434
• Device Sequence Number: 725362
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 06/29/2021
• Device Catalogue Number: 02.12.0002L
• Device Lot Number: 163318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 08/03/2017
• 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: 64 YR