MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COLLARED FEMORAL STEM SIZE 3 LAT; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.243

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 september 2015: lot 147183: (b)(4) stems manufactured and released on 13 february 2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported issue.On (b)(6) 2015 the medical affairs director made the following comment: a stem of same size as the originally-planned one has been inserted and looks well positioned.Therefore, the patient had to bear no consequence from this event except a slightly increased operative time.There are no other clinically relevant aspects of this claim.On 10 september 2015 the r&d project manager analysed the returned implant: observing the femoral stem no particular sign can be noted, except under the collar: such a sign was probably caused during the removal phase.A dimensional a documental control is currently underway at our cq department.To date, it is not possible from the inspection of the implant determine the root cause of the event.On 11september 2015 a dimensional check was made in cq department: the implant is in compliance with the stem design.On the same date the r&d project manager added the following: the dimensional and documental analysis on the returned coated stem (metrological analysis of the cq department done by means of the transparent templates used to control the forges of the implant) showed the total conformity of the returned prosthesis.The root cause of the complaint cannot be determined.

Event Description

It was not possible to hammer the amistem collared ha s.3 lat.The surgeon rasped several times, but the stem again and again stuck 4 mm higher as the last rasp.It has been opened the new implant amistem collared ha s.3 lat (different lot) which has been placed in patient without any difficulty.

Manufacturer Narrative

On 17 september 2015 it was prepared a final report with the information already submitted in the initial report.On 12 october 2015 the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H COLLARED FEMORAL STEM SIZE 3 LAT
• 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 ; 91 6966060
• MDR Report Key: 5070972
• MDR Text Key: 25559471
• Report Number: 3005180920-2015-00190
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 01.18.243
• Device Lot Number: 147183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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): Required Intervention