MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 2; CEMENTED HIP STEM

Catalog Number	01.18.152
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/16/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 145436: 100 items manufactured and released on (b)(6)2014.Expiration date: (b)(6) 2019.No anomalies found related to the issue.To date, all the 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 is planned.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: partial revision surgery in a hybrid tha patient after 3,5 years.Reasons for revision are not specified, nor is primary diagnosis.The implantation technique is rather unusual, particularly for a well-renowned center, because the stem appears to be small for the femoral canal, the resection level is rather low and at an oblique angle, with the femoral plug placed far distal to the stem.Also the choice for a cemented stem in a young male patient is rather unusual: there may have been situations there were not reported and that drove surgery and surgical strategy.We could not identify a problem clearly linked to the implanted devices.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7291624
• Report Number: 3005180920-2018-00084
• Device Sequence Number: 877257
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• 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: 2014
• 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: 09/12/2014
• Device Catalogue Number: 01.18.152
• Device Lot Number: 145436
• 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: 55 YR