MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123152

Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Discomfort (2330); Injury (2348)

Event Date 01/24/2011

Event Type  Injury  

Event Description

It was reported a right hip revision due to persistent pain and discomfort in his hips and heard it popping on numerous occasions.Head explanted.Implanted s&n femoral head along with a non bhr implant aesculap stem.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup/ head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other complaints have been identified for the head.Similar complaints have been identified for the cup and this 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.Device history record review confirmed that all released parts met specifications applicable at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.The medical documents were reviewed.The intraoperative findings of avascular necrosis of the femoral neck is consistent with the patient¿s chronic history of avn and is not associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr head and bhr cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr head.Similar complaints have been identified for the bhr cup.This will continue to be monitored.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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The revision operative report noted avascular necrosis of the femoral neck in the area of the prosthetic interface.The surgeon noted that this was the source of the failure.The intraoperative findings of avascular necrosis of the femoral neck is consistent with the patient¿s chronic history of avascular necrosis and is not associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.Based on the available information, the root cause of the revision is not product related due to the patient history of avascular necrosis.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

New information: g4, d4.

• Brand Name: FEMORAL HEAD 52MM
• 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: 9532608
• MDR Text Key: 173108948
• Report Number: 3005975929-2019-00464
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74123152
• Device Lot Number: 08DW16672
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74122158 ACET CUP HAP SIZE 52/58 07HW12975
• Patient Outcome(s): Hospitalization; Required Intervention