MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS TERMINAL CUP IMPACTOR FOR METAL BACK; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.15.10.0161

Device Problem Misconnection (1399)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information received on the 30 august 2017 and includes: the terminal cup impactor became damaged as a result of this surgery.It was not damaged before hand.The surgeon finished the surgery with another impactor.Additional information received on the 31 august 2017 and includes: the terminal for cup impactor fell out of the implant after impaction.Batch reviews performed on 19 september 2017.(b)(4).

Event Description

Whilst impacting the definitive implant, the thread of the versafitcup failed.It is unknown whether or not this is a result of the terminal cup impactor not being screwed into the shell correctly.The patient's wound was thoroughly washed out to ensure that no debris was left there as a precaution.The shell was not implanted.The surgeon used another shell of the same size and complete the surgery without delay.There was no harm to the patient.

Manufacturer Narrative

On on 22 september 2017 the r&d project manager performed a visual inspection of the retrieved item and commented as follows: during the inspection it is evaluated that the threaded part of the terminal is damaged and, in addition, there are some scratches both on the balinit-c terminal and on the inner surface of the implant cup.Probably the surgeon impacted the cup without a complete screwing of the cup before and this caused the breakage of the thread part.

• Brand Name: AMIS TERMINAL CUP IMPACTOR FOR METAL BACK
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• 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: 6886388
• MDR Text Key: 89389784
• Report Number: 3005180920-2017-00531
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0161
• Device Lot Number: 1413789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 84