MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP 52MM WITH IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

Device Problem Compatibility Problem (2960)

Patient Problems Failure of Implant (1924); Injury (2348); Neuralgia (4413); Metal Related Pathology (4530)

Event Date 05/07/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient left hip due to severe pain, limited mobility, elevated metal ion levels and metallosis.Among the intra-operative findings were adverse soft local tissue reaction with fluid collections around the implant; metallosis and elevated metal ions as a result of the premature failure of the device.The patient's outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that left hip revision surgery was performed.During the revision the bhr cup remained implanted and the bhr head was removed these devices were used in treatment.As of today 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, hemi head and modular sleeve 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 cup.Similar complaints have been identified for the bhr head.However, as bhr systems of this size are no longer sold, no action is to be taken.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.The clinical information provided, of the reported elevated metal ion levels and soft tissue reaction may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.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

H3, h6: it was reported that left hip revision surgery was performed.During the revision the bhr head was removed.The bhr cup remained implanted.The devices were used in treatment.As of today, 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 cup.Similar complaints have been identified for the bhr head.However, as bhr systems of this size are no longer sold, no action is to be taken.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.The primary surgery was done almost 8 years prior to the revision surgery.The implantation operative report and chartstiks listed the bhr acetabular cup as a 52-mm; however, the surgeon noted ¿sequential reaming of the acetabulum up to a size 52 socket which gave us good pressfit.We then impacted the real size 50 socket into place.¿ the revision surgery was reportedly done (b)(6) 2019 secondary to ¿adverse soft local tissue reaction with fluid collections around the implant; metallosis and elevated metal ions as a result of the premature failure of the device¿.However, none of this was mentioned in the revision operative report.The impact to the patient beyond the pain, the revision surgery and the recovery cannot be determined.The clinical information provided, of the reported elevated metal ion levels and soft tissue reaction may be consistent with a reaction to metal debris.It cannot be concluded based on the chartstik and the implant report if the surgeon under-reamed the size of the shell.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.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: ACETABULAR CUP HAP 52MM WITH IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10671865
• MDR Text Key: 211101452
• Report Number: 3005975929-2020-00383
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Device Lot Number: 11AW31315
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention