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

Model Number	01.18.142
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2020: lot 131644: (b)(4) items manufactured and released on 02-aug-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 2016.Clinical evaluation performed by medical affairs manager: stem revision performed 6 years after primary cementless total hip arthroplasty.In the radiographic image provided, radiolucent lines are visible in gruen zone 1 and 2 and the stem looks undersized.The reason of this choice cannot be assessed on the basis of anteroposterior postoperative radiographic projection.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 project manager preliminary visual investigation shows head with signs of extraction as well for femoral neck.Stem show residual spots of ha.It is not possible to determine an implant related failure root cause.
Event or Problem Description
6 years and 4 months after primary the surgeon revised the patient hip for stem loosening.Stem and head revised successfully.

• 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: 10343413
• Report Number: 3005180920-2020-00454
• Device Sequence Number: 824686
• 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: 2014
• 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): 07/30/2020

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: 06/30/2018
• Device Model Number: 01.18.142
• Device Catalogue Number: 01.18.142
• Device Lot Number: 131644
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/30/2020
• 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