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 UNKN01102102

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 12/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after a primary unspecified bhr construct had been implanted on the patient¿s left 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

It was reported that surgery was performed on the patient's left hip.As of today, the implanted devices all of which were used in the treatment remain implanted and therefore cannot be evaluated.Additional information has been requested for this complaint but has not become available.Without definitive lot numbers, a complete complaint history review cannot be performed for the devices involved.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling and ifu review could not be performed.All of the devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.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 information was 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 return of the actual devices or further information we cannot further investigate or confirm the reported 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 the results of this investigation, the need for corrective or preventative action is not indicated.B3 date of occurrence corrected.

• 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: 12806613
• MDR Text Key: 280743274
• Report Number: 3005975929-2021-00533
• 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: 01/25/2022

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: UNKN01102102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• 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: A
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 40 KG