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

Model Number 74121150

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 07/30/2009

Event Type  Injury  

Event Description

Left hip revision surgery of the femoral head only was performed.Component was "grossly loose".Subsequent revision previously reported via mdr 3005975929-2018-00130.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the bhr head was removed.The bhr cup remains implanted.As of today, device return and additional information has been requested for this complaint but has not become available.The device batch/lot details have not been received therefor no thorough manufacturing record review and assessment of the reported event can be performed.The available medical documents were reviewed.No information or implantation report were provided.According to the provided revision report, the femoral component was grossly loose and the cup was left in-vivo as there was no wear and it was without wear and burnishing.Based on the available information, the reason of the loosening cannot be determined.No information was provided that indicated a septic loosening and aseptic loosening can be assumed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient's particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

This complaint was re- opened due to further information.It was reported that left hip revision surgery was performed.During the revision the bhr head was removed.The bhr cup remained implanted at the time of the (b)(6) 2009 revision.It was also noted this patient subsequently underwent further revision on this same hip on (b)(6) 2017 (reviewed under (b)(4)).As of today, device return and additional information has been requested for this complaint but has not become available.The device batch/lot details have not been received therefore no thorough manufacturing record review and assessment of the reported event can be performed.The available medical documents were reviewed.No information or implantation report were provided.According to the provided revision report, the femoral component was grossly loose and the cup was left in-vivo as there was no wear and it was without wear and burnishing.Based on the available information, the reason of the loosening cannot be determined.No information was provided that indicated a septic loosening and aseptic loosening can be assumed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.The available medical documents were reviewed.A 2009 x-ray indicated the implant on the femoral side shifted into varus.No medical images beyond the implantation intraoperative x-ray was provided for comparison.The revision intraoperative report indicated the femoral component was grossly loose.It cannot be determined to what extent the patients physical activity as a personal trainer and fitness consultant had on the position of the implant and his reported pain.Also, without pre-revision x-rays to determine implant anatomical placement and any micro-motion over time, this cannot be ruled out as a contributory factor to the reported issue.All the released devices involved met manufacturing specifications at the time of production.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, 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.

• 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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 7506455
• MDR Text Key: 107995633
• Report Number: 3005975929-2018-00160
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502797
• UDI-Public: 03596010502797
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: 74121150
• Device Catalogue Number: 74121150
• Device Lot Number: 71849
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120156, LOT # UNKNOWN; ACETABULAR CUP, # 74120156, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR