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

Model Number	01.18.142
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-dec-2019.Lot 155236: (b)(4) items manufactured and released on 07-mar-2016.Expiration date: 21.02.2021.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.Preliminary investigation performed by r&d project manager femoral stem shows ha residual in central and proximal part of the stem.Neck taper with sign of revision.Clinical evaluation performed by medical affairs manager.Partial hip revision surgery (femoral component) performed 3 years after primary cementless total hip arthroplasty.No information concerning patient age, general health status and comorbidities is available.Radiographic images provided show the presence of radiolucent lines around the stem and signs of stress shielding.Aseptic loosening is a possible 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
Revision surgery performed 2 years after primary due to stem loosening.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d hip project manager: visual investigation highlights residual ha on the proximal stem, in line with the revision cause stated by the surgeon.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9525235
• Report Number: 3005180920-2019-01109
• Device Sequence Number: 2651160
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 02/21/2021
• Device Model Number: 01.18.142
• Device Catalogue Number: 01.18.142
• Device Lot Number: 155236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 07/21/2020
• 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