MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 2; HIP CEMENTLESS STEM

Model Number 01.18.132

Device Problems Failure to Osseointegrate (1863); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 13.08.2020: lot 148432: (b)(4) items manufactured and released on 24-mar-2015.Expiration date: 2020-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation: stem revision performed 5 years after primary cementless total hip arthroplasty in a (b)(6) year-old man.In the radiographic images provided, radiolucent lines and signs of stress shielding are visible.The stem looks slightly undersized but the reason of this choice cannot be assessed on the basis of postoperative x-rays.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: preliminary investigation performed on 1st september 2020.From the received photo it is not possible to determine the root cause of the event: the stem appears without any visible signs or damages and the event seems not to be related to a failure device.Further investigations will be done after receiving the implant.

Event Description

Stem mobilization due to non-osseointegration after 4 years and 11 months after the primary surgery.The stem has been revised.The patient feel pain and tight after 4 years from the primary.No infection was present.

Manufacturer Narrative

Visual inspection: from the received photo it is not possible to determine the root cause of the event: the stem appears without any visible signs of damage and the event seems not to be related to a device failure.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 2
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10482080
• MDR Text Key: 205471268
• Report Number: 3005180920-2020-00534
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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
• Device Operator: No Information
• Device Expiration Date: 02/28/2020
• Device Model Number: 01.18.132
• Device Catalogue Number: 01.18.132
• Device Lot Number: 148432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR