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

Catalog Number 74122154

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/22/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pain, bone spur, fluid around the hip, weakening bone, bone loss & impingement, loosening and rotation, loss of mobility and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain, bone spur, fluid around the hip, weakening bone, bones loss, impingement, loosening and rotation, loss of mobility and metallosis.During revision the bhr cup and the bhr head were remowed.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.According to the provided revision report, the patient had pain and clicking since several months before the revision.During the surgery, evidence of metallosis and medial defect of the acetabulum were noted.There was some bone weakening at the posterior femoral neck that was related to an impingement with the acetabulum.The acetabular component was described to be in approximately 70° anteversion.It was suspected origin from migration after implantation and assumed as the reason for the metallosis.The provided implantation report indicated that the cup was implanted in 25° anteversion.Based on the provided information, a relation between the reported metallosis, medial defects, clicking and pain and the cup anteversion or the impingement cannot be excluded.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: 7352446
• MDR Text Key: 102864190
• Report Number: 3005975929-2018-00107
• 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
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 74122154
• Device Lot Number: 14BW05981
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 74123148, LOT 14CW02052; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR