MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/60; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122160

Device Problems Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/09/2020

Event Type  Injury  

Event Description

It was reported that during surgery prior inserting the acetabular, it was noticed that one of the wire loops had snapped and the component had loosened in the inserter making it difficult to securely seat the acetabular component in the correct position and alignment.Delay less than 30 min, no injury reported.No backup device was available.

Manufacturer Narrative

It was reported that during surgery prior to inserting the acetabular cup, it was noticed that one of the wire loops had snapped and the component had loosened in the inserter making it difficult to securely seat the acetabular component in the correct position and alignment.The introducer wire & cup collar were returned for inspection.A visual inspection was carried out on the introducer wire which confirmed that the wire had snapped, there was no visual damage to the cup collar, this confirms the reported complaint.A review of the complaint history for the cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the cup.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Device history record review confirmed that all released parts met specifications applicable at the time of production.Additionally the introducer wire & cup collar were reviewed and were confirmed as acceptable.A risk management review was performed.No additional risks were identified as a result of the reported event.No further actions are required at this time.It should be noted as per the surgical technique that when attaching the cup using the wires and cup introducer, tension should be applied until the cup is securely attached to the introducer assembly.Care should be taken with over tightening and excessive wire tension as this may lead to wire breakage.After investigation, the potential root cause is user error, it cannot be concluded that the functional complications were associated with a mal-performance of the implant.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETABULAR CUP HAP SIZE 52/60
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9927074
• MDR Text Key: 186522505
• Report Number: 3005975929-2020-00098
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552327
• UDI-Public: 03596010552327
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74122160
• Device Catalogue Number: 74122160
• Device Lot Number: 19GW15767
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1