MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2019: lot 180725: (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-06-12.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 manager: femoral fracture occurred few days after cementless total hip arthroplasty in a (b)(6) woman.The event occurred during the walking rehabilitation period of time where a sudden movement on a weakened bone due to intraoperative preparation may facilitate the occurrence of bone fractures.There is no reason to suspect a faulty device.Preliminary investigation performed by r&d project manager: from preliminary visual analysis, it is not possible to relate any failure root cause to the implant.
Event or Problem Description
9 days after the primary the patient presented a fracture at the level of the lesser trochanter.The surgeon revised the stem and the ceramic head successfully.
Additional Manufacturer Narrative
On 10 may 2019 the r&d project manager made the following analysis on the retrieved devices: femoral stem shows small scratches on the neck right under the taper.Ha layer is intact.It is not possible to highlight an implant-related failure root cause.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8260595
• Report Number: 3005180920-2018-01112
• Device Sequence Number: 2056296
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 06/12/2023
• Device Catalogue Number: 01.18.402
• Device Lot Number: 180725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 06/21/2019
• 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: 68 YR
• Patient Weight: 75