MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD FEMORAL HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123148

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Pain (1994); Toxicity (2333); Injury (2348)

Event Date 02/25/2018

Event Type  Injury  

Event Description

It was reported that a right hip revision surgery was performed due to pain in his right hip extending to the groin area, elevated chromium and cobalt levels, as well as pseudo-cyst.

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 have been requested for this complaint but have not become available.A review of the complaint history for the head and cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No similar 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.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.The available medical documents were reviewed.Based on information provided, the reported pain, elevated metal ion levels, pseudocyst, and intraoperative findings of metal staining and fluid, may be consistent with findings associated with metal debris.Without supporting radiographic images, lab/pathology reports and/or the analysis of the explanted components, the source of the reported findings cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.It is noted the subject had bilateral resurfacing devices.It is unknown the status of the contralateral hip and if the metal ions elevation could be related.The patient impact beyond the revision and expected post-operative healing/pain 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: FEMORAL HEAD 48MM
• 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: 9683190
• MDR Text Key: 178204183
• Report Number: 3005975929-2020-00047
• 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
• Report Date: 10/22/2020

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: Lay User/Patient
• Device Expiration Date: 08/30/2013
• Device Catalogue Number: 74123148
• Device Lot Number: 08HW18425
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 07/09/2020; 08/18/2020
• Supplement Dates FDA Received: 07/14/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74122154 ACET CUP HAP SIZE 48/54 09BW21857
• Patient Outcome(s): Hospitalization; Required Intervention