MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120148

Device Problems Device Slipped (1584); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

As this complaint is also being handled through smith & nephew's legal teams, any responses to these queries are not immediately available to the members of smith & nephew's regulatory team and are not expected to be available for several months, if ever.This is because the timing of device return / the delivery of the information is in the control of the patient's solicitors, not smith & nephew.Smith & nephew's legal teams have confirmed that if they receive additional relevant information on this complaint (reason for complaint, including part/lot, patient, surgeon, device availability, dates of implantation or revision), they will inform us, at which point the complaint will be reopened for investigation.

Event Description

It was reported that right hip revision surgery was performed due to metallosis, with loosening of hardware and bone loss.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the head and the cup 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.The bhr 42mm head and bhr 48mm od cup are no longer sold by smith & nephew.A review of the complaint history for the 48mm acetabular cup and the 42mm femoral 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 head.Similar complaints have been identified for the acetabular cup.However, as the device is no longer sold, no action is to be taken.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.Patient had a right birmingham hip replacement 8/23/2010.Eight years post implantation she had a revision using depuy components.The surgeon¿s noted indications for the procedure were severe pain, large mass and loosening of the femoral and acetabular components.The intraoperative report noted severe bone loss around the acetabular and femoral components and soft tissue mass.The reported pain and soft tissue mass may be consistent with findings associated with metallosis; however, without the supporting lab/pathology results, imaging, and/or 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: ACETLR CUP HAP 48MM W/ IMPTR
• 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: 8801646
• MDR Text Key: 151406874
• Report Number: 3005975929-2019-00271
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 74120148
• Device Lot Number: 076584
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121142 RESURFACING FEM HEAD 42MM 66656; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention