MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE FEMORAL COMPONENT; CEMENTED FEMORAL COMPONENT

Catalog Number	02.12.0007L
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director made the following analysis: aseptic mobilization of cemented tkr after little more than two years.In a slightly valgus knee patient.The radiograph shows detachment between cement mantle and tibial bone; only one projection is available.With the information available, no conclusion can be drawn as to the root cause of this adverse event, but there is no indication of a faulty implant.Batch review performed on 22 december 2017: lot 147222: (b)(4) items manufactured and released on 16 february 2015; expiration date: 2020-01-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere tibial insert fixed flex #5/11 mm l ref.(b)(4) lot.141422 (k140826): lot 141422: 74 items manufactured and released on 29 april 2014; expiration date: 2019-03-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk tibial tray fixed cemented # 5 l ref.(b)(4) lot.150915 (k090988): lot 150915: (b)(4) items manufactured and released on 28 april 2015; expiration date: 2020-03-31.No anomalies found related to the issue.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 cause of pain is unknown.The surgeon revised the insert, tibia and femur.The surgery was completed successfully.

• Brand Name: GMK SPHERE FEMORAL COMPONENT
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142965
• Report Number: 3005180920-2017-00772
• Device Sequence Number: 927661
• Product Code: JWH
• UDI-Device Identifier: 07630030825897
• UDI-Public: 07630030825897
• 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
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: 01/31/2020
• Device Catalogue Number: 02.12.0007L
• Device Lot Number: 147222
• 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: 11/22/2017
• Initial Report FDA Received Date: 12/22/2017
• 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
• Patient Age: 62 YR