MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM, HA COATED STEM SIZE 0 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.230

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

On 17 august 2017 the r&d project manager performed a preliminary investigation based on the available images and commented as follows: in the images of both braoch and stem no particular sign can be noted.We will wait to receive the stem for dimensional controls: that in order to confirm the equivalence between broach and stem.To date, the root cause of the event cannot be determined.Batch review performed on 18 august 2017.Lot 170841: (b)(4) items manufactured and released on 06 april 2017.Expiration date: 2022-03-28.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 Description

The surgeon tried to implant the amistem-h collared stem size 0 after rasping, but the stem was not able to fit in the canal prepared with broach size 0.It was floated about 5mm height.The surgeon simply change for new stem size 00 and it was fit and fixed strongly.Due to this event, the surgery was prolonged about 10 minutes.The surgery was completed successfully.

Manufacturer Narrative

On 15 september 2017 the r&d project manager performed a visual inspection of the retrieved stem and commented as follows: no particular signs can be noted, except some scratches on the neck probably due to the removal of the stem.A dimensional control has been performed, which identified nor anomalies nor defects.According to the dimensional control, the stem and the broach conform to the drawing.The root cause of the event cannot be determined.

• Brand Name: AMISTEM COLLARED STEM, HA COATED STEM SIZE 0 STD
• Type of Device: CEMENTLESS FEMORAL 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: 6803628
• MDR Text Key: 83201397
• Report Number: 3005180920-2017-00457
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804557
• UDI-Public: 07630030804557
• 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,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 01.18.230
• Device Lot Number: 170841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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: 64 YR