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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330); Toxicity (2333)

Event Date 07/20/2014

Event Type  Injury  

Event Description

It was reported a bilateral bhr patient that underwent for a revision due to persistent pain and discomfort in his hips.In addition, plaintiff currently has elevated metal ion levels in his blood which is indicative of metallosis and/or potential failure of the metal-on-metal implant devices.

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 head/ sleeve/ cup/ stem 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 stem & head.Similar complaints have been identified for the cup and this will continue to be monitored.Similar complaints have been identified for the sleeve.However, as this device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.It was also confirmed that all devices were sterilised.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.The medical documents were reviewed.The revision document does not note findings consistent with the complaint description of metallosis or elevated metal ions.The reported pain, pus and fibrinous tissue may be consistent with infection; however, the root cause of the infection cannot be confirmed.The infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The patient impact beyond infection, 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: ACETABLR CUP HAP
• 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: 9872524
• MDR Text Key: 184712396
• Report Number: 3005975929-2020-00089
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention