MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 8 L; CEMENTED HIP STEM

Catalog Number	01.18.153
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 february 2018: (b)(4).
Event or Problem Description
On 24 january 2018 the sales representative has been informed by the surgeon that a revision surgery was performed.At this time we do not know if the reason of the revision surgery is bone fracture or stem loosening.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: few days after primary hybrid tha on an elderly lady, femoral stem revision is required.The reason is not specified in the report.The radiographic images show a varus-positioned stem that probably left no cement on the medial proximal surface, a low resection level and a very distal femoral plug.The distal cement is thoroughly detached from the bone, reasons unknown, possibly because of insufficient cleaning or pressurization.There a re no indications that a defective device led to this adverse event.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 8 L
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7291619
• Report Number: 3005180920-2018-00087
• Device Sequence Number: 19096363
• Product Code: LZO
• UDI-Device Identifier: 07630030804304
• UDI-Public: 07630030804304
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: 05/16/2022
• Device Catalogue Number: 01.18.153
• Device Lot Number: 170831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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: 78 YR