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

Catalog Number 74120160

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Pain (1994)

Event Date 06/03/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed.Patient had a fall, dislodging the acetabular cup and causing pain.Extensive metallosis debris noted during revision.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.The patient had a fall, dislodging the acetabular cup and causing pain.During revision the bhr cup, hemi head and modular sleeve were removed, however the anthology stem 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 known 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.The available medical documents were reviewed.Review of the provided revision report indicates that the patient was asymptomatic until a fall when the cup dislodged and the patient had strong pain leading to the revision.During the revision copious amounts of dark metallosis fluid and solid was seen in the joint, at the acetabulum and at the trunnion.The cup was found loose and there were lesions at the pubic bone and ileum.Based on the provided information it remains unclear whether there is a relation between the reported metallosis and the dislodgement of the cup after the fall.Further details about the nature of the intraoperative findings remain unknown without additional information such as from a histopathological analysis and post-operative and follow-up x-rays.Without the device available, it remains unclear whether the reported metallosis relates to an increased amount of wear or material loss at the taper junctions and/or a loose/migrating cup.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.It was however noted that the patient was asymptomatic until after a fall (traumatic injury).The bhr surgical technique relevant for the cup involved includes in its warnings: +excessive physical activity levels, excessive patient weight, and trauma to the joint replacement may cause early failure of the implant.+component loosening or migration due to trauma, loss of fixation, malalignment, or bone resorption.Based on the provided information it remains unclear whether there is a relation between the reported metallosis and the dislodgement of the cup after the fall, and as such 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7059376
• MDR Text Key: 92945750
• Report Number: 3005975929-2017-00414
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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 Expiration Date: 01/31/2013
• Device Catalogue Number: 74120160
• Device Lot Number: 083247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71356007, LOT # 08CM13164; HEMI HEAD, # 74122558, LOT # 10206; MODULAR SLEEVE, # 74222300, LOT # 10069
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR