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 Biocompatibility (2886)

Patient Problems Infiltration into Tissue (1931); Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

Us legal: it was reported that, after right birmingham hip resurfacing surgery was performed in 2013 due to pain, stiffness, catching and decreased activity capabilities, the patient experienced pain, significantly elevated chromium and cobalt ions and gluteus tendinosis.It is unknown if any intervention was performed.

Manufacturer Narrative

H10: additional information in d6a and h6 (updated health effect - clinical code and health effect - impact code) h3, h6.It was reported that after right birmingham hip resurfacing surgery, patient experienced pain, significantly elevated chromium and cobalt ions and gluteus tendinosis.It is unknown if any intervention was performed.As of today, the implanted devices, which were all used in treatment, remain implanted in the patient and therefore cannot be evaluated.However, it is currently unclear if a revision surgery has already been conducted, indicated or scheduled.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 reported tendonosis cannot be ruled out as a contributing factor to the reported pain.With the information provided the clinical root cause of the reported elevated metal ions cannot be confirmed; however, the reported ¿metallosis¿ of the contralateral hip cannot be ruled out as a contributing factor to the elevated metal ions.The patient impact beyond the pain and elevated metal ions cannot be determined.Based on the available information we can confirm the reported complaint, however without further information our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive physical activity levels, unreasonable stress on replacement system, excessive patient weight, trauma to the joint replacement, loosening of components may increase production of wear particles and accelerate damage to the bone.Should the devices or additional information be received, the complaint will be reopened.Based on this 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: 14102123
• MDR Text Key: 289176659
• Report Number: 3005975929-2022-00159
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2022
• 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): Other
• Patient Sex: Female