MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE1; CEMENTLESS HIP STEM

Catalog Number	01.18.231
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2018.Lot 177349: (b)(4) items manufactured and released on 28 february 2018.Expiration date: 2023-02-19.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: femoral fracture occurred 10 days after primary surgery in a (b)(6) lady, probably significantly overweight.No trauma was reported.The fracture probably occurred during the rehabilitation period of time where a sudden movement on a weakened bone due to the normal intraoperative femoral preparation may favour this event.The quality of the postoperative image does not allow to detect an existing fracture line.The stem is positioned in valgus and probably higher than normal, but the relation of these observations to the event are not certain.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed due to bone fracture 10 days after primary.The patient didn't report about any trauma.According to the surgeon, the fracture could have been originated by the implanted prosthesis.The surgeon revised the patient on (b)(6) 2018 with a corail stem end zimmer strapping cables.

• Brand Name: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8155023
• Report Number: 3005180920-2018-00990
• Device Sequence Number: 13764172
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K121011
• 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
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2023
• Device Catalogue Number: 01.18.231
• Device Lot Number: 177349
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/12/2018
• 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: 66 YR
• Patient Weight: 72