MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED LAT STEM SIZE 8; CEMENTLESS HIP STEM

Catalog Number	01.18.248
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 february 2019: lot 154547: (b)(4) items manufactured and released on 28-jan-2016.Expiration date: 2021-01-16.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.Clinical evaluation performed by medical affairs director hip revision surgery occurred 2 months after primary total hip arthroplasty in a (b)(6) year old heavy ((b)(6) kg) patient with a very large cylindrical femur.Radiographic images provided show a probably subsided stem.Causes of this event may be undersized stem and low bone quality.However, no preoperative nor immediate postoperative x-ray, that would allow more detailed clinical evaluation, is available.The reason of this event cannot be determined.Preliminary investigation performed by r&d product manager.Implant covered in biological fluids.Preliminary analysis does not highlight any implant-related failure root cause.
Event or Problem Description
The surgeon revised the patient hip for a stem subsidence.All hardware swapped successfully.

• Brand Name: AMISTEM COLLARED HA COATED LAT STEM SIZE 8
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8357661
• Report Number: 3005180920-2019-00085
• Device Sequence Number: 2284633
• Product Code: LZO
• UDI-Device Identifier: 07630030804731
• UDI-Public: 07630030804731
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 01/16/2021
• Device Catalogue Number: 01.18.248
• Device Lot Number: 154547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/21/2019
• 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: 65 YR
• Patient Weight: 100