MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121142

Device Problem Compatibility Problem (2960)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 01/05/2015

Event Type  Injury  

Event Description

Plaintiff underwent medically-indicated revision of the bhr left hip implants on (b)(6) 2015.The patient revision surgery was performed due to severe pain, failed left hip resurfacing, elevated levels of cobalt and chromium, stiffness, loss of mobility, and metallosis.

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 have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.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.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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.

Event Description

Plaintiff underwent medically-indicated revision of the bhr left hip implants on (b)(6) 2015.The patient revision surgery was performed due to severe pain, failed left hip resurfacing, elevated levels of cobalt and chromium, stiffness, loss of mobility, and metallosis.The patient was discharged after 2 days in stable condition.

Manufacturer Narrative

Sections a2, a3, b5, b6, d1, d3, d4, g4, h4 and h6 were updated according to the new information received.Internal complaint reference number: (b)(4).

Manufacturer Narrative

H3, h6: 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 have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified for the cup and head and these failures 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 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 and 40-45° inclination angle.However, the implantation operative report indicated the acetabular component was implanted at approximately 20-25° anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the metallosis noted intraoperatively.As well, the patient¿s fall cannot be ruled out as a contributing factor to her pain and clinical status.The reported pain, stiffness, loss of mobility, elevated metal ions, and intraoperative findings of ¿moderate amount of greenish tissue¿ and pseudotumor may be consistent with metallosis.However, the root cause of the reported metallosis cannot be confirmed nor can it be concluded that the clinical reactions are associated with a mal-performance 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.Based on the limited information provided we are unable to speculate the specific factors known to contribute to the alleged fault.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative action is not indicated.

• Brand Name: RESURFACING FEMORAL HEAD 42MM
• 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: 10556043
• MDR Text Key: 207601968
• Report Number: 3005975929-2020-00345
• 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: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2021

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: 08/29/2012
• Device Catalogue Number: 74121142
• Device Lot Number: 077834
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/22/2020; 07/16/2021; 10/15/2021
• Supplement Dates FDA Received: 09/25/2020; 07/22/2021; 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR