MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HE; BHR ACETABULAR CUP

Catalog Number 74121150

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Toxicity (2333); Injury (2348); Ambulation Difficulties (2544); Test Result (2695)

Event Date 08/27/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pain, difficulty walking, elevated chromium and cobalt levels, metallosis and device failure.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the 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.No further actions are required at this time.The available medical documents were reviewed.The reported elevated metal ion levels, pain, and granulomatosis-type changes noted intraoperatively are consistent with an adverse reaction to metal debris; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Also, without the implantation and pre-revision x-rays to determine initial implant anatomical placement and any micro-motion over time (for loosening), this cannot be ruled out as a contributory factor to the reported clinical reactions.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 HE
• Type of Device: BHR ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7929171
• MDR Text Key: 122447152
• Report Number: 3005975929-2018-00349
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 74121150
• Device Lot Number: 10MW31275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• 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; Required Intervention
• Patient Age: 61 YR