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

Model Number	74122160
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005975929-2020-00098
• Device Sequence Number: 16827521
• Product Code: NXT
• UDI-Device Identifier: 03596010552327
• UDI-Public: 03596010552327
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2024
• Device Model Number: 74122160
• Device Catalogue Number: 74122160
• Device Lot Number: 19GW15767
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 04/05/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1