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

Catalog Number UNKN01102110

Device Problem Biocompatibility (2886)

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Solid Tumour (4552); Unspecified Tissue Injury (4559)

Event Date 05/27/2021

Event Type  Injury  

Event Description

*us legal mdl* it was reported that, after a bhr tha construct had been implanted on (b)(6) 2008, the plaintiff experienced joint pain, metallosis, elevated ion levels, and difficulty to ambulate.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.During revision surgery, a cloudy murky fluid was found in the joint, as well as metal debris, a pseudotumor requiring excision, adverse local tissue reaction and neurolysis of the sciatic nerve.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery has been performed.As of today, the implanted devices all of which were used in the treatment, and 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 and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications.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 documentation was reviewed.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (elevated metal ion levels, cloudy murky fluid in joint, and pseudotumor) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Without return of the actual devices or further information we cannot further investigate or confirm 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.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI
• 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
• MDR Report Key: 12135176
• MDR Text Key: 260479308
• Report Number: 3005975929-2021-00344
• 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
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention