MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0; HIP STEM

Model Number	01.18.130
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 august 2021: lot 163086: (b)(4) items manufactured and released on 01-sep-2016.Expiration date: 2021-08-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold.Another similar event has been reported on this lot since 2017.Clinical evaluation performed by medical affairs manager: femoral component (stem, head and liner) revision performed 4 years and 7 months after primary cementless total hip arthroplasty in a young ((b)(6) year old) woman.No information concerning patient general health status and level of activity is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by r&d manager: the stem has been explanted due to loosening.It has been primarily implanted at beginning (b)(6) 2016.Looking at the image it is visible that the ha on the stem body has been completely absorbed by patient bone as expected.There are some signs and scratches on the neck part probably due to revision surgery.Also the explanted ceramic head is visible in the photo, with some scratches on the bottom probably due to revision surgery.It is not possible to determine the root cause of reported stem loosening.Visual inspection performed by r&d manager: during this analysis it is confirmed what reported in the preliminary investigation, nothing more to add.
Event or Problem Description
Revision surgery 4 years and 7 months after primary due to stem loosening.The surgeon revised the stem, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager.Femoral component (stem, head and liner) revision performed 4 years and 7 months after primary cementless total hip arthroplasty.No information concerning patient general health status and level of activity is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Batch review performed on (b)(6) 2021.Lot 163086: (b)(4) items manufactured and released on 01-sep-2016.Expiration date: 2021-aug-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.Piece was returned on 5 august 2021.Patient is 71 years old.

• Brand Name: STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12352961
• Report Number: 3005180920-2021-00668
• Device Sequence Number: 17115578
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 08/21/2021
• Device Model Number: 01.18.130
• Device Catalogue Number: 01.18.130
• Device Lot Number: 163086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: Other; Required Intervention
• Patient Age: 71 YR