MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.172
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 14 may 2018 by medical affairs manager: femoral stem loosening 8 months after primary cementless total hip arthroplasty in a (b)(6) year old man.Radiographic images provided show the presence of radiolucent lines in gruen zones 1, 2, 6 and 7 and signs of stress shielding.Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown.The reason of this failure cannot be determined batch review performed on 28 may 2018; lot 161299: (b)(4) items manufactured and released on 08 april 2016.Expiration date: 2021-03-29 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed on 28 may 2018 by r&d product manager: the coating of the stem appeared almost totally present in the stem: the presence of the coating can indicate an incorrect osseointegration with the femur, although signs of regrowth bone were found in the distal part of the coating.Moreover, some small signs of removal were found in the taper area.From the received piece it is not possible to determine the root cause of the event.
Event or Problem Description
About 8 months after primary surgery the surgeon revised the patient hip due to stem loosening.The surgeon swapped successfully the stem.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7549087
• Report Number: 3005180920-2018-00379
• Device Sequence Number: 16597738
• Product Code: LZO
• UDI-Device Identifier: 07630030804373
• UDI-Public: 07630030804373
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: 03/29/2021
• Device Catalogue Number: 01.18.172
• Device Lot Number: 161299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/29/2018
• 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: 69 YR
• Patient Weight: 60