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

Catalog Number	02.12.0002L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the patient matched department performed a planning review for this case reporting as follows: our analysis of the planning process of this case found no deviations from the standard procedures.Each step has been performed correctly.Batch review performed on 20 november 2017.Lot 141225: (b)(4) items manufactured and released on 17 march 2014.Expiration date: 2019-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-sphere tibial tray fixed cemented code 2 left, code 02.07.1202l, lot.144880 (k090988) (b)(4) items manufactured and released on 07 august 2014.Expiration date: 2019-06-30.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 tibial and femur bone deformed till the final breakage.The reason of deformation is unknown.Revision performed.All the devices were removed and a gmk-revision implanted.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2 LEFT
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7057081
• Report Number: 3005180920-2017-00694
• Device Sequence Number: 11080894
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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: 02/28/2019
• Device Catalogue Number: 02.12.0002L
• Device Lot Number: 141225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/23/2017
• 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: 71 YR
• Patient Weight: 89