MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP MODULAR HEAD (BHMH); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333); No Code Available (3191)

Event Date 06/06/2019

Event Type  Injury  

Event Description

Us legal it was reported that a revision surgery was performed on the patients right hip due to pain, elevated metal ion levels, and pseudotumors.The patient outcome is unknown.

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.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.

• Brand Name: BIRMINGHAM HIP MODULAR HEAD (BHMH)
• 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: 10179510
• MDR Text Key: 195972955
• Report Number: 3005975929-2020-00211
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTHOLOGY HIP IMPL; BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR; ANTHOLOGY HIP IMPL; BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR
• Patient Outcome(s): Hospitalization; Required Intervention