MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 4; CEMENTLESS STEM

Model Number	01.18.144
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 march 2020: lot 114068: (b)(4) items manufactured and released on 12-jan-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stam, head and liner) performed 8 years after cementless total hip arthroplasty in a (b)(6) year old man.Radiographic image provided shows the presence of radiolucent lines around the stem and signs of stress shielding suggesting proximal implant mobilization.Aseptic loosening is a possible long term, literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
Stem head and liner revised, 8 years after primary surgery, due to stem loosening.
Additional Manufacturer Narrative
Device was returned on 03-apr-2020 and it was analyzed.Visual inspection performed by r&d project manager femoral stem with ha residuals in the proximal region.Signs of revision on neck and head.Pe liner with signs and typical color of years of implantation, and signs of removal.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9909735
• Report Number: 3005180920-2020-00201
• Device Sequence Number: 11581250
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 12/31/2016
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 114068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: 67 YR
• Patient Weight: 81