MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121150

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

Patient Problems Osteolysis (2377); Metal Related Pathology (4530); Solid Tumour (4552)

Event Date 10/19/2022

Event Type  Injury  

Event Description

It was reported that, a plaintiff underwent a right primary bhr procedure on (b)(6) 2006, due to hip pain.Later, plaintiff was diagnosed with raised metal ions and experienced pain.A revision surgery was performed on (b)(6) 2022 to treat this event.During procedure, the synovium was noticed to be black, and an anterior pseudotumor and osteolysis was found around the neck.The bhr cup was well fixed and showed no damage; therefore, only the femoral head was explanted, and a combination of zimmer and s+n devices were implanted.The patient was taken to the post operative area in excellent condition.No other complications have been reported.

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.

Manufacturer Narrative

H3, h6: it was reported that, a patient underwent a right primary bhr procedure due to hip pain.Later, the patient was diagnosed with raised metal ions and experienced pain.A revision surgery was performed to treat this event.During procedure, the synovium was noticed to be black, and an anterior pseudotumor and osteolysis was found around the neck.The bhr cup was well fixed and showed no damage; therefore, only the femoral head was explanted, and a combination of zimmer and s+n devices were implanted.The patient was taken to the post operative area in excellent condition.No other complications have been reported.As of today, the implanted femoral head used in treatment has not been returned for evaluation and the cup remains implanted and therefore cannot be tested.A review of the historical complaints data for the alleged devices was performed using batch numbers, part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified for the head and no other similar complaints for the cup, and this failure will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.The review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.No further escalation actions are required.The available medical documents were reviewed.The bhr surgical technique (smith & nephew-0011) indicates ¿the acetabular component is then fully impacted with 20° of anteversion and 45° open.¿ without the implantation and pre-revision x-rays, it cannot be determined if the ¿40 degrees anteversion¿ of the acetabular component was the initial anatomical placement of the implant or if the implant migrated post-operatively; however, this cannot be ruled out as a contributory factor the reported clinical reactions.The reported raised metal ions, pain, osteolysis, and black synovium and pseudotumor may be consistent with findings associated with metal debris; however, the clinical root cause of the reported reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Based on the information provided, further investigation of the reported complaint cannot be carried out and remains inconclusive.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: RESURFACING FEMORAL HEAD 50MM
• 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: 17935149
• MDR Text Key: 325678944
• Report Number: 3005975929-2023-00148
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P040033
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74121150
• Device Lot Number: 58862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 74120158/ACETLR CUP HAP 58MM W/ IMPTR.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male