MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122540

Device Problems Compatibility Problem (2960); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671); Metal Related Pathology (4530)

Event Date 09/26/2018

Event Type  Injury  

Event Description

It was reported that, after a r3-tha construct had been implanted on the right hip in (b)(6) 2010, the patient had severe pain, limited mobility, elevated cobalt and chromium levels, and metallosis.A revision surgery was performed on (b)(6) 2018 to treat the adverse event.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: it was reported that a revision surgery was performed.All of the implanted devices were used in treatment.As of today, additional information has been requested for this complaint but have not become available.A review of the complaint history for the r3 liner, r3 shell, stem, 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 stem, r3 liner and r3 shell.Similar complaints have been identified for head and sleeve however, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the 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's instructions for use 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.The reported pain, elevated cobalt and chromium levels and operative findings of corrosion at the head neck junction may be consistent with findings associated with trunnionosis and metallosis; however, the root cause of the pain, elevated cobalt and chromium levels and trunnionosis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were 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 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.

• Brand Name: HEMI HEAD 40MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10440089
• MDR Text Key: 203981126
• Report Number: 3005975929-2020-00310
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2013
• Device Catalogue Number: 74122540
• Device Lot Number: 08HW18318
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CN: 74222100, LN: 08EW16958.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR