MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121154

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

Patient Problems Pain (1994); Discomfort (2330); Injury (2348)

Event Date 07/18/2011

Event Type  Injury  

Event Description

It was reported a left 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 left 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.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.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.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion; however, the implantation operative report indicated the acetabular component was implanted at 10-15 ° anteversion.It is unknown if the anteversion led to accelerated wear of the prosthesis and the elevated chromium and pathological finding of metal wear reaction.The patient¿s history of chronic avascular necrosis cannot be ruled out as a contributing factor to the reported pain and intraoperative findings of synovitis.The root cause for the ¿heterotopic bone¿ cannot be concluded.Some patients can be genetically predisposed, as it is a known complication of joint surgeries and is related to the procedure and not the device.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 left 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.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion.However, the implantation operative report indicated the acetabular component was implanted at 10-15 ° anteversion.The patient¿s history of chronic avn cannot be ruled out as a contributing factor to the reported pain and intraoperative findings of synovitis.The root cause for the ¿heterotopic bone¿ cannot be concluded but some patients can be genetically predisposed, it is a known complication of joint surgeries and is related to the procedure and not the device.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

New information: g4, d4.

• Brand Name: RESURFACING FEMORAL HEAD 54MM
• 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: 9532486
• MDR Text Key: 173110048
• Report Number: 3005975929-2019-00462
• 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,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: 02/28/2013
• Device Catalogue Number: 74121154
• Device Lot Number: 085349
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120160 ACETLR CUP HAP 60MM W/ IM 083222
• Patient Outcome(s): Hospitalization; Required Intervention