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

Model Number	01.18.147
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 18 february 2020: lot 111711: (b)(4) items manufactured and released on 18-jul-2011.Expiration date: 2016-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: femoral component (stem and head) revision performed 8 years after primary cementless total hip arthroplasty in an elderly ((b)(6) year old) man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, regions of reduced bone density around the proximal profile of the stem and signs of stress shielding are visible.Aseptic loosening is a possible literature described long-term 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 project manager: preliminary visual investigation highlights residual ha on proximal femoral stem and signs of osseointegration on distal stem.
Event or Problem Description
Revision surgery due to stem loosening, stem and head revised.Primary was performed in (b)(6) 2012.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9726276
• Report Number: 3005180920-2020-00069
• Device Sequence Number: 2500463
• Product Code: LZO
• UDI-Device Identifier: 07630030804236
• UDI-Public: 07630030804236
• 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
• Report Date (Section B): 02/19/2020

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: 06/30/2016
• Device Model Number: 01.18.147
• Device Catalogue Number: 01.18.147
• Device Lot Number: 111711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• 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: 81 YR