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

Catalog Number UNKN01102106

Device Problem Biocompatibility (2886)

Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931); Discomfort (2330); Osteolysis (2377); Weight Changes (2607); Osteopenia/ Osteoporosis (2651); Embolism/Embolus (4438); Metal Related Pathology (4530)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that, after a primary unspecified bhr construct had been implanted on the patient¿s right hip on (b)(6) 2010, the patient experienced elevated chromium levels in blood (21.58 ug/l) as revealed by a blood test result performed on (b)(6) 2019.Per patient¿s correspondence, she has experienced weight loss, an unspecified infection in the body, clogged blood vessels, advanced bone degradation and the appearance of a slight noise in the implant area.It is unknown if a revision surgery has already been conducted, indicated and/or scheduled to treat this adverse event.The patient does not complaint of pain in the area of the prosthesis.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that after a primary unspecified bhr construct had been implanted on the patient¿s right hip, the patient experienced elevated chromium levels and an appearance of a slight noise in the implant area.As of today, the implanted devices, which were all used in treatment and additional information have been requested but have not become available.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 investigation, a complaint history review, manufacturing record review, device labelling / ifu review could not be performed.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 devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.The available medical documents were reviewed.With the information provided the clinical root cause of the elevated chromium cannot be confirmed and based on the provided images stability and the orientation of the femoral heads cannot be ruled out as factors on one or both sides.It cannot be concluded the elevated chromium and reported ¿weight loss, unspecified infection, clogged blood vessels, advanced bone degradation, and slight noise in the implant area¿ are associated with a malperformance of the implant or implant failure.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.B3 date of event is unknown.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD
• 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: 12806650
• MDR Text Key: 284691062
• Report Number: 3005975929-2021-00532
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2021
• 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: A
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 40 KG