MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

Device Problem Compatibility Problem (2960)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/21/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip due to severe pain, limited mobility, elevated cobalt and chromium levels.The patient outcome is unknown.

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.No part/lot numbers were provided; hence documentation review could not be completed.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.The available medical documents were reviewed.Based on the translated documents, the reported pain and elevated cocr levels, metallosis may be consistent with findings associated with metal debris.Without complete supporting medical documents, radiographic images, 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.Also, based solely on the translation of the provided lab and revision op reports, it is unknown whether the patient had any underlying comorbidities, or whether the reported assault which resulted in a fall on her hip may have been contributing factors to the reported and revision.Due to the limited documentation and translation, the cause for the acetabular/ischium fracture and cause of the 2nd revision is unclear and osteolytic change from the reaction to wear debris cannot be ruled out.It cannot be concluded that the revision was due to a mal-performance of the implant.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: UNKNOWN BIRMINGHAM HIP MODULAR HEAD (BHMH) IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 10277490
• MDR Text Key: 198919355
• Report Number: 3005975929-2020-00254
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP MODULAR HEAD SLEEVE; UNKN STEM
• Patient Outcome(s): Hospitalization; Other; Required Intervention