MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED STD STEM SIZE 6; CEMENTLESS HIP STEM

Catalog Number	01.18.136
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 145417: 106 items manufactured and released on 09 october 2014.Expiration date: (b)(6) 2019.No anomalies found related to the problem.To date, 104 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: partial hip revision surgery (head and stem) in a (b)(6) year old active woman 3 years after primary total hip arthroplasty.Radiographic images provided show the presence of osteolysis and bone resorption in the greater trochanter region, prolonged along the lateral aspect of the stem.Radiolucent lines are visible in gruen zone 1.Presumably as a consequence of osteolysis, the stem got loose.The origin of the osteolysis cannot be determined with the information at hand.
Event or Problem Description
About 3 years after primary the surgeon revised the patient for a stem loosening.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7458392
• Report Number: 3005180920-2018-00272
• Device Sequence Number: 1160841
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: 01.18.136
• Device Lot Number: 145417
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/25/2018
• 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: 53 YR