MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)

Patient Problems Injury (2348); Test Result (2695); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was report the patient's right hip has loosened, resulting in the requirement for revision surgery.Patient is scheduled to have an aspiration on (b)(6) 2016 on the right hip.

Event Description

Devices were originally implanted in (b)(6) 2010.Revision surgery is scheduled for (b)(6) 2016.

Manufacturer Narrative

It was reported that right hip revision surgery was performed on a bilateral patient.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup & bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes no other similar complaints were identified for the head.Similar complaints have been identified for the cup, this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The medical documents were reviewed.The heterotopic ossification cannot be ruled out as a contributing factor to the reported pain.Based on the available information, the root cause for the ¿heterotopic ossification¿ cannot be concluded but some patients can be genetically predisposed it is a known complication of joint surgeries and is related to the procedure and not the device.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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: 5369180
• MDR Text Key: 36036034
• Report Number: 3005477969-2016-00018
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74121146
• Device Lot Number: 090094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120152 ACETLR CUP HAP 52MM W/ IM 094001.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR