MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 03/23/2013

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on right hip due to loosening of implant.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to loosening of implant.During revision, the bhr head was removed, however 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 known devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.According to the provided revision report, the patient developed pain and inability to weight-bear.During the revision the femoral component was described as grossly loose and under the component the bone was possibly necrotic.The cup was well fixed, in 30° anteversion and left in-vivo.Suggested by the surgical technique is an anteversion of 20°.Based on the limited information, the nature of the reported loosening remains unclear and no contributing factors could be identified or excluded and the report of ¿possibly necrotic¿ bone under the femoral component is noted.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.

• Brand Name: RESURFACING FEMORAL HEAD 46MM
• 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: 7614165
• MDR Text Key: 111489050
• Report Number: 3005975929-2018-00224
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 74121146
• Device Lot Number: 081773
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.; CUP HAP 52MM 74120152 LOT 081779; BHR FEMORAL HEAD/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR