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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Test Result (2695)

Event Date 02/12/2019

Event Type  Injury  

Event Description

It was reported that elevated metal ions were found in the patient.This event was untreated but revision surgery was scheduled; the date of the revision is still unknown.

Manufacturer Narrative

It was reported that revision surgery was scheduled.The implanted were all used in treatment.As of today, additional information has been requested for this complaint but have not become available.As no device batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labelling / ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.The available medical documents were reviewed.All documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No additional s&n devices have been revised.Should clinical documentation become available, the clinical/medical investigation may be re-evaluated.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: BHR ACETABULAR CUP
• 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: 8550839
• MDR Text Key: 143107163
• Report Number: 3005975929-2019-00177
• 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: study
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Other