MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE1 L; CEMENTED HIP STEM

Catalog Number	01.18.151
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 155668: 60 items manufactured and released on (b)(6) 2015.Expiration date: (b)(6) 2020.No anomalies found related to the issue.To date, 57 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 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 months after primary hybrid tha in an elderly female patient a revision is to be performed.Reasons that led to revision surgery are not specified.Cementation technique appears to be improvable but we are not concluding that this is the cause for such an early failure.Information supplied is not sufficient to draw any conclusion.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE1 L
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7291629
• Report Number: 3005180920-2018-00091
• Device Sequence Number: 13768421
• Product Code: LZO
• UDI-Device Identifier: 07630030804267
• UDI-Public: 07630030804267
• 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: 2016
• Device Explanted Year: 2016
• 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 Catalogue Number: 01.18.151
• Device Lot Number: 155668
• 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: 81 YR