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

Catalog Number UNKNOWN

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Metal Related Pathology (4530)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that the plaintiff underwent a left hip revision surgery on (b)(6) 2020 due to elevated metal ion levels in blood and pseudotumor formation.During the procedure, it was noticed that there was extensive infection of the periprosthetic tissues with loss of bone substance on the posterior femoral wall and exposure of about half of the prosthesis.At this time, it was decided to perform a 2-step revision surgery and the m-o-m system was replaced with antibiotic spacers.The second step of the 2-step revision surgery was performed on (b)(6) 2020, and during this procedure, the antibiotic spacers were explanted and replaced with an unspecified tha system.During the procedure, the patient suffered from a fracture of the greater trochanteric bone which was treated with a plate and fixed with metal clips.The current state of health of the patient is unknown.The primary left hip procedure was performed on (b)(6) 2008.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that the patient underwent a left hip revision surgery due to elevated metal ion levels in blood and pseudotumor formation.During the procedure, it was noticed that there was extensive infection of the periprosthetic tissues with loss of bone substance on the posterior femoral wall and exposure of about half of the prosthesis.A two stage revision procedure was therefore performed.During the second procedure, the patient suffered from a fracture of the greater trochanteric bone which was treated with a plate and fixed with metal clips.The devices, used in treatment, were not returned for evaluation.Without a provided part or batch number, a complaint history, historic escalation actions or manufacturing records review for the devices cannot be completed.Should more information be provided at a later date, this task will be reopened and completed.Review of the current product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed and no additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Based on the reported symptoms it cannot be concluded that the events/clinical reactions (elevated metal ion levels, pseudotumor formation, and extensive infection of the periprosthetic tissues with loss of bone substance on the posterior femoral wall and exposure of about half of the prosthesis) were associated with a mal-performance of the implant.The patient impact cannot be determined at this time.Based on the information provided 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.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 action is not indicated.Corrected data: d4 (catalog number), h6 (health effect - clinical code).

• Brand Name: UNKN BIRMINGHAM HIP IMPL
• 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: 17502275
• MDR Text Key: 320909964
• Report Number: 3005975929-2023-00109
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2023
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female