MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number UNKNOWN

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Unequal Limb Length (4534)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Event Description

Us legal.It was reported that the plaintiff underwent a left hip revision surgery due to pain, stiffness, and a mechanical failure (loosening) of the components.The surgeon also noted that the patient had a leg length discrepancy.During the revision surgery, both bhr components were explanted and replaced with a tha system from a competitor.The patient tolerated the procedure well.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.As of today, device return and additional information has been requested for this complaint but has not become available.As no device part and batch numbers were provided for the acetabular cup and femoral head for investigation, a complaint history review, manufacturing record review, device labelling / ifu review and historical review of the escalation actions could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical documents were reviewed.The intraoperative findings of a well-fixed femoral component and well ingrown acetabular component does not support the reported mechanical failure of loosening.The reported pain, stiffness and leg length discrepancies are consistent with the surgeon¿s noted hip flexion contracture, supported by the intraoperative finding of ¿deep adherent scar tissue.¿ the root cause for the scar tissue cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.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.Based on the information provided, we can confirm this complaint.Scar tissues are known complications of surgeries and a probable root cause related to the procedure and not the device.Should the devices or additional information be received, the complaint will be reopened.Based on the investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14047235
• MDR Text Key: 289781431
• Report Number: 3005975929-2022-00128
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male