MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.18.141
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 09 february 2018: total hip revision surgery occurred 6 years after primary cementless tha in a (b)(6) kg woman.Radiographic image provided shows the presence of signs of stress shielding suggesting insufficient proximal stem fixation.During revision procedure, the surgeon decided to remove also the acetabular component that was well fixed but excessively anteverted.Reasons for aseptic loosening of the stem cannot be determined.Cup position was certainly suboptimal but its contribution to loosening cannot be established.Batch review performed on 19 february 2018 (b)(4).
Event or Problem Description
About 6 years after primary the surgeon revised the patient due to stem loosening and malpositioned cup.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7285375
• Report Number: 3005180920-2018-00074
• Device Sequence Number: 1110021
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2018

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: 03/31/2016
• Device Catalogue Number: 01.18.141
• Device Lot Number: 110563
• 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: 01/22/2018
• Initial Report FDA Received Date: 02/21/2018
• 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: 68 YR
• Patient Weight: 82