MAUDE Adverse Event Report: LIMACORPORATE S.P.A. IMPACTOR - POSITIONER - ALIGNER; HWA

Model Number 9057.20.555

Device Problems Separation Failure (2547); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The check of dhr of the lot # involved did not show any anomaly on the 55 delta tt cups (lot # 201509574) and the 15 impactors (lot # 201002361) manufactured with the same lot #.30 out of 55 delta tt cups manufactured with the lot # 201509574 were implanted and no other complaint was received on both the lot numbers involved.About the impactor: this instrument has been probably used many times because it is on the market since 2010, and no other complaints were reported on the lot #.We received the delta tt cup and the impactor used in surgery.The devices underwent a functional test with a go-no go gauge: both the thread of the acetabular cup and the impactor resulted to be fully functional.We also performed a functional test to simulate the use of the pieces during surgery: the impactor was completely screwed into the acetabular cup thread, then the impaction of the cup was performed by hammering onto the impactor.After this, it was possible to unscrew the impactor from the cup, confirming the functionality of the devices.Based on the above analysis, there are no defects on both the instrument and cup.The cause of this intra-operative issue may have been the excessive strength applied by the surgeon when screwing the impactor into the cup.This, combined with the stresses caused to impact the cup, could have prevented the unscrewing of the impactor from the cup during the surgery.Additionally, the delta system surgical technique specifies that the impactor involved (9057.20.555) must not be used with definitive cups, but only with trial cups.A wrench is provided specifically for the impaction of the definitive cup: the wrench is to be used in combination with modular adaptors, that help preventing the deformation of the cup during impaction.According to limacorporate post market surveillance data, (b)(4).

Event Description

The definitive delta tt acetabular cup was positioned and impacted into the acetabulum with the impactor (9057.20.555).After impaction, it was not possible to separate the impactor from cup.Male thread of the impactor was seized inside female thread of cup.The cup had to be removed together with impactor, and a new cup of the same size was implanted with the shorter impactor available.The surgery was successfully completed with no consequences for the patient.Surgery time extended of 20 minutes.Event occurred in (b)(6).

• Brand Name: IMPACTOR - POSITIONER - ALIGNER
• Type of Device: HWA
• Manufacturer (Section D): LIMACORPORATE S.P.A.; IT
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 5697194
• MDR Text Key: 47745596
• Report Number: 3008021110-2016-00026
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9057.20.555
• Device Lot Number: 201002361
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2010
• 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): Hospitalization