MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; BHR ACETABULAR CUP

Catalog Number 74121142

Device Problems Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Toxicity (2333); Osteolysis (2377); Tissue Breakdown (2681); Test Result (2695)

Event Date 06/25/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Patient reported severe pain, elevated levels of cobalt and chromium, metal debris and inflammation, metallosis, cobalt toxicity, necrotic tissue, bone and tissue loss, loss of mobility, loss of strength and pseudotumors.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the femoral head was removed.The acetabular cup remained implanted.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 cup + 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 cup.Similar complaints have been identified for the head and this failure will continue to be monitored.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.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.Although the cobalt and chromium levels were reported to be in the 30s, neither the exact levels, the unit of measure, the date the sample was collected, nor the lab report was provided.It is unknown what type of devices were implanted in the left hip or if they could have contributed to the reported elevated cobalt and chromium levels.It should be noted that a female patient is a contraindication of bhr.The reported pain, elevated cobalt and chromium levels, lesion, debris, stained material, and inflammation are consistent with findings associated with metallosis; however, without the supporting lab results, imaging, and the analysis of the explanted components, the root cause of the reported reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 42MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: sarah freestone
• MDR Report Key: 7929414
• MDR Text Key: 122459126
• Report Number: 3005975929-2018-00354
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/19/2021

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: 08/31/2012
• Device Catalogue Number: 74121142
• Device Lot Number: 078599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN; PART NUMBER: 74120150 / LOT NUMBER: 075776; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female