MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122160

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/07/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to a lack of boney in-growth.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to reported metal debris and elevated cobalt and chromium levels.During the revision the bhr head and bhr cup were removed.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.According to the provided revision report, the patient did initially well but then developed posterior subluxations when deep squatting during weight lifting.The patient had elevated blood metal ions and one day before the revision the patient developed sudden pain and grinding symptoms.Intra-operative findings were a loose acetabular component, a clear joint fluid, mild synovitis and mild degree of debris.It was not specified to what type of debris this relates (metal or bone).Additionally, there was a mild lateral erosion of the acetabular rim, which was described as ¿mechanical¿.Aseptic loosening may have various root causes such as inadequate initial fixation, mechanical loss of fixation or particle induced osteolysis.As no x-rays of the device in-vivo were provided, possible contributing factors related to implant position, bony cup integration or patient anatomy cannot be further investigated.The role and nature of the mentioned debris, subluxation or rim erosion remain unclear.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: BHR ACETABULAR CUP 60MM
• 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: 7406128
• MDR Text Key: 104658093
• Report Number: 3005975929-2018-00120
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552327
• UDI-Public: 03596010552327
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 74122160
• Device Lot Number: 12AW35682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74123152, LOT # 16BW12839; FEMORAL HEAD, # 74123152, LOT # 16BW12839
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR