MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM

Catalog Number 74120158

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.Only the acetabular cup was revised.It was reported that the surgeon mis-implanted the acetabular cup.Implantation was in (b)(6) 2006; revision was in (b)(6) 2011.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During revision the bhr cup was removed and the bhr head remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.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.The available medical documents were reviewed.An x-ray showed the acetabulum appeared to be about 70 to 80 degrees vertical, with evidence for ingrowth.It should be noted bhr is contraindicated in patients who are immunosuppressed or persons receiving high doses of corticosteroids.It cannot be determined to what extent the patient¿s comorbidities, chronic pain and heavy narcotic use had on his pain and clinical status.The surgeons indication for revision was malposition of the acetabular components.The vertical position of the acetabulum cannot be ruled out as a contributing factor to the pain and clinical status of the patient and it cannot be concluded that the reported events are 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.Based on the available information a potential root cause of improper loading has been selected due to the implant movement / migration.If the product 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: BHR ACETABULAR CUP 58MM
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house spa park; harrison way; leamingon spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 3978479
• MDR Text Key: 21728647
• Report Number: 3005477969-2014-00444
• 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,Company Representative,company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2010
• Device Catalogue Number: 74120158
• Device Lot Number: 53756R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART #74121150 AND LOT #61700; FEMORAL HEAD, PART #74121150 AND LOT #61700
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR