MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR SLVD MODULAR HEAD 38MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74222138

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Pain (1994); Metal Related Pathology (4530)

Event Date 11/21/2018

Event Type  Injury  

Event Description

It was reported that, after a r3-tha construct had been implanted in the right hip, the plaintiff underwent medically-indicated revision on (b)(6) 2018 due to painful loosening of the acetabular or femoral components that resulted from metallosis, soft tissue damage, and pseudo-tumors.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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 r3 shell, r3 liner, modular head, modular sleeve, synergy stem and 20mm screw 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 r3 shell, modular head, synergy stem and 20mm screw.Similar complaints have been identified for the r3 liner and modular sleeve.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 and no further actions are required at this time.The available medical documents were reviewed.It is unknown if the verticality as well as relative retroversion of the acetabular component led to accelerated wear and the turbid fluid, caseating appearing material and black corrosion debris noted intraoperatively.The root cause of the reported pain, pseudotumor, elevated metal ions and intraoperative findings of turbid fluid, caseating appearing material and black corrosion debris 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 reported revision and pain 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.

Manufacturer Narrative

Sections d3, d4, d10 and h6 were updated.Internal complaint reference number: (b)(4) section b3 was corrected.

Event Description

*row legal* bilateral patient.Plaintiff underwent medically-indicated revision of the r3-tha right hip implants on (b)(6) 2018.The revision surgery was performed due to painful loosening of the acetabular or femoral components that resulted from metallosis, soft tissue damage, and pseudo-tumors.The patient outcome is unknown.

• Brand Name: BHR SLVD MODULAR HEAD 38MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 11100221
• MDR Text Key: 224517539
• Report Number: 3005975929-2020-00541
• 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,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2011
• Device Catalogue Number: 74222138
• Device Lot Number: 10264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71306111SYN POR HO FEM COM SZ 11; 71332520 REF SPHER HEAD SCREW 20MM; 71335550R3 3 HOLE ACET SHELL 50MM; 74222200MODULAR SLEEVE {} PLUS 0MM 12/14; CN: 74222200. LN: 08AW15331; CN: 74222200. LN: 08AW15331
• Patient Outcome(s): Hospitalization; Required Intervention