MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number 01.18.234

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 17 april 2018; lot 172626: (b)(4) items manufactured and released on 11 october 2017.Expiration date: 2022-10-01; 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.Preliminary investigation performed by r&d product manager on 19 april 2018: evaluating the images attached to this complaint it seems that the broach is functionally conform.There are only some little scratches visible on the broach surface, due to the usage, that we can consider acceptable.There is no evidence related to the fact that the surgeon wasn't able to insert the stem size 4 in the femur after canal preparation.Visual inspection performed by r&d product manager on 20 april 2018: the stem appeared without any particular sign, except for the scratches related to the difficult removal (signs under the collar, groove in the neck).From the received piece it is not possible to determine the root cause of the event.

Event Description

After having used the broach size #4, the surgeon tried to implant the stem size #4, but it floated about 7mm up.The surgeon replaced it with a stem size #3.It took about 40 minutes for retrieving.The broach was not defective.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 4
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7446376
• MDR Text Key: 106024691
• Report Number: 3005180920-2018-00257
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804595
• UDI-Public: 07630030804595
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 01.18.234
• Device Lot Number: 172626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR