MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; HIP CEMENTLESS STEM

Catalog Number	01.18.137
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: partial hip revision surgery occurred 6 years after cementless total hip arthoplasty in a heavy (b)(6) man at time of implantation.Radiographic image provided shows the presence of radiolucent lines in gruen zones 1 and 7 suggesting implant mobilization.Aseptic loosening is a possible, literature described mid term adverse event and causes are often unknown.The reason of this event cannot be determined.Batch review performed on 27 may 2019: lot 110840: (b)(4) items manufactured and released on 05-may-2011.Expiration date: 2016-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without another similar reported event [mdr2019-00204].Visual inspection performed by r&d project manager: tha layer completely absorbed.Deep scratch on one side, probably due to implant removal.It is not possible to determine the failure root cause.
Event or Problem Description
About 6 years after primary revision surgery for stem loosening.The surgeon revised successfully the stem and the ceramic head and liner.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649828
• Report Number: 3005180920-2019-00425
• Device Sequence Number: 14261923
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 01.18.137
• Device Lot Number: 110840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/29/2019
• 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: 59 YR
• Patient Weight: 93