MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 52MM; PROSTHESIS, HIP, FEMORAL, RESURFACING

Catalog Number 74123152

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Date 09/19/2011

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pain and other complications, including a loose femoral component.Revision of femoral head component only.

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to pain and other complications, including a loose femoral component.During the revision the bhr head was removed but 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.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.Review of the implantation report did not reveal any inconsistencies related to the surgical technique that could explain the later revision.According to the provided revision report, the patient had pain and radiologic signs of loosening.During the revision, normal join fluid was noted, the femoral neck was not grossly loose and the cup remained in-vivo.Based on the provided information the reason for the pain and whether in-fact loosening occurred remains unclear.Further assessment is not possible based on the limited information.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

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, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.The first revision for the left hip was done just 7 months post implantation secondary to ¿pain and loosening of the femoral component¿.The root cause of the pain and loosening from the first revision on the left side cannot be concluded with the documentation available.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.Additional information: a4 and d4.

• Brand Name: FEMORAL HEAD 52MM
• Type of Device: PROSTHESIS, HIP, FEMORAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 6759600
• MDR Text Key: 81575707
• Report Number: 3005975929-2017-00239
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 03596010552433
• UDI-Public: 03596010552433
• 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
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 74123152
• Device Lot Number: 10FW28627
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 07/11/2017; 07/11/2017; 07/11/2017
• Supplement Dates FDA Received: 02/23/2018; 02/11/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP PART # 74122158, LOT # NI.; ACETABULAR CUP, # 74122158, LOT # 10JW30086.; ACETABULAR CUP PART # 74122158, LOT # NI
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 98