MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 1; HIP CEMENTLESS STEM

Catalog Number	01.18.141
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 181651: items manufactured and released on 18 july 2018.Expiration date: 2023-07-03.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: immediate postoperative revision due to femoral perforation in a young obese ((b)(6) kg) patient.The event is probably due to preparation issues: patient size may have reduced visibility of the anatomical structures.There is no reason to suspect a faulty device.
Event or Problem Description
Immediate post-op surgery x-rays (the same day as primary surgery) revealed that the stem perforated the femur and placed with a false root.Revision surgery performed the same day through amis approach performed successfully repositioning and replacing the stem.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8780214
• Report Number: 3005180920-2019-00558
• Device Sequence Number: 14113203
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 07/03/2023
• Device Catalogue Number: 01.18.141
• Device Lot Number: 181651
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/11/2019
• 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: 36 YR
• Patient Weight: 120