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

Catalog Number	02.12.0022R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: the single image provided shows the presence of a proximal tibial fracture.Due to the little information provided, it is not possible to define the real cause of this event.It seems that no traumatic event was reported.Patient's characteristics such as female gender and age ((b)(6)) may be associated to the bone weakening that could have favoured the occurrence of fracture.However, based on the available information, the reason of this event cannot be determined.Batch review performed on 22 august 2017.Lot 152903: (b)(4) items manufactured and released on 06 july 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.
Event or Problem Description
After the primary surgery, the patient alleged the pain.X-rays was taken several days after and found the bone fracture.Hospitalization was prolonged.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ RIGHT
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6819955
• Report Number: 3005180920-2017-00473
• Device Sequence Number: 1522531
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2017

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: 05/31/2020
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 152903
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/25/2017
• 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: 80 YR