MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ RIGHT

Catalog Number	02.12.0023R
Health Effect - Clinical Code	Joint Disorder (2373)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 12 october 2017.Lot 165997: (b)(4) items manufactured and released on 23 november 2016.Expiration date: 2021-11-09.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.Gmk-sphere tibial insert fixed flex size 2/20 mm right, code 02.12.0220fr, lot.146637 (k121416) (b)(4) items manufactured and released on 19 june 2015.Expiration date: 2020-05-31.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.Gmk-sphere femoral wedge distal size 3/4mm, code 02.07.304fdw, lot.151201 (k102437) (b)(4) items manufactured and released on 15 may 2015.Expiration date: 2020-02-29.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.Gmk-sphere femoral wedge posterior size 3/10mm, code 02.07.310fpw, lot.102529 (k102437) (b)(4) items manufactured and released on 14 october 2010.Expiration date: 2020-11-10.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.Gmk-sphere extension stem - fluted ø 11 l 65, code 02.07.Fcl11065, lot.161029 (k120790) (b)(4) items manufactured and released on 08 april 2016.Expiration date: 2021-04-07.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
The patient came in complaining of pain.The surgeon determined the patient is presenting with ligamentous instability.The cause is unknown.The surgeon is requesting a custom insert.The revision surgery was completed successfully on (b)(6) 2017.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ RIGHT
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6944542
• Report Number: 3005180920-2017-00578
• Device Sequence Number: 11048006
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 11/09/2021
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 165997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: Required Intervention