MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123156

Device Problems Material Discolored (1170); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377)

Event Date 09/28/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to pain and significant reaction to the metal on metal hip implant with discoloration and osteolysis.

Manufacturer Narrative

It was reported that a revision surgery of the right hip was performed due to pain, also that the patient suffered a significant reaction to the metal on metal hip implant with discoloration, and osteolysis.During the revision, the bhr cup and bhr head were removed.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 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 for the head or cup.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.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 available medical documents were reviewed.The patient¿s reported pain, reaction to the mom hip implant with discoloration, and osteolysis which is noted in the legal claim cannot be confirmed, as the revision operative report does not provide details of osteolysis or avn.Therefore, it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected post-surgical healing 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: FEMORAL HEAD 56MM
• 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: 8249570
• MDR Text Key: 133116901
• Report Number: 3005975929-2019-00021
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2013
• Device Catalogue Number: 74123156
• Device Lot Number: 08KW19370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP 74122162/10CW26259; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/ UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR