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

Catalog Number	01.18.141
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 july 2019: lot 165577: (b)(4) items manufactured and released on 10-jan-2017.Expiration date: 2021-12-13.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.
Event or Problem Description
Reason for revision was due to secondary fracture below stem.Secondary fracture occurred 4 months and a half after primary (3 months and 1 week after first fracture) thus we were alerted on (b)(6) 2019 that the revision of stem and femoral head would be performed on (b)(6) 2019.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager on august 19th 2019: revision surgery performed after the second femoral fracture occurred in a patient previously fixed with plate and screws.The reason of fracture is unknown: probably the patient (a 77 year old woman) presented risk factors for fracture occurrence but this cannot be confirmed as no information concerning general health status and/or comorbidities is available.A sudden unexpected movement or a subclinical trauma may be possible reasons.There is no reason to suspect a faulty device.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8893109
• Report Number: 3005180920-2019-00662
• Device Sequence Number: 1617672
• Product Code: LZO
• UDI-Device Identifier: 07630030804175
• UDI-Public: 07630030804175
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 12/13/2021
• Device Catalogue Number: 01.18.141
• Device Lot Number: 165577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: 76 YR