MAUDE Adverse Event Report: HPF S.P.A. AMIS CUP IMPACTOR-M10 (HPF); SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.15.10.0535

Device Problem Separation Failure (2547)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer was alerted on (b)(6) 2018.On the 2nd may 2018 the manufacturer reported: batch released on date: 16/october/2017.N.Of pieces released: 15.All the steps, according to our routing sheet and relative drawings, have been performed correctly as well as the dimensional and functional controls.No other similar event registered on this lot there aren't non conformity elements in the document review.Analyzing the pictures above, we notice that the damaged part is the joint of the rotation mechanism.We suppose that the rupture concerning the laser welding is due to an improper use of the instrument.We suppose that an higher rotation force had been exerted exceeding the resistance of the device.Visual inspection performed on 30 april 2018 by r&d product manager although it cannot be confirmed, it is possible that the device was used in a non-standard way, causing an excessive rotational force on the broken joint exceeding the resistance of the device.The images provided in the preliminary investigation were considered.

Event Description

The surgeon could not disengage the broken cup impactor from the cup so he removed both from the patient.After this event, the surgeon had to implant a size 56 instead of a size 54.

• Brand Name: AMIS CUP IMPACTOR-M10 (HPF)
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): HPF S.P.A.; via pinzano, 24; flagogna, italy 33030 ; IT 33030
• MDR Report Key: 7525803
• MDR Text Key: 108741973
• Report Number: 3005180920-2018-00342
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0535
• Device Lot Number: 17HD121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Distributor Facility Aware Date: 04/18/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR