MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P LAT STEM SIZE 4; HIP CEMENTLESS STEM

Catalog Number	01.18.414
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.Batch review performed on 06 may 2019: lot 180745: (b)(4) items manufactured and released on 05-jul-2018.Expiration date: 2023-06-25.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
During final implant insertion the stem sunk 4mm and a small distal fissure was detected.The surgery was completed successfully implanting a competitor stem.
Additional Manufacturer Narrative
On (b)(6) 2019 we have received the stem and head involved in the complaint.Visual inspection performed by r&d project manager: fully intact ha layer on the stem, ceramic head with metal transfer scratch.

• Brand Name: AMISTEM-P LAT STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8591156
• Report Number: 3005180920-2019-00350
• Device Sequence Number: 2169592
• Product Code: LZO
• UDI-Device Identifier: 07630040720137
• UDI-Public: 07630040720137
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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: 06/25/2023
• Device Catalogue Number: 01.18.414
• Device Lot Number: 180745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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: Other
• Patient Age: 58 YR
• Patient Weight: 71