MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Toxicity (2333)

Event Date 04/26/2017

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to painful right hip metallosis, tiredness, fatigue, emotional mood swings, memory problems and elevated metal ion levels.

Manufacturer Narrative

It was reported that a right hip revision surgery was performed due to pain, metallosis, tiredness, fatigue, emotional mood swings, memory problems and elevated metal ion levels.At the time of the revision, the hemi head, bhr cup, and modular sleeve were removed, with the femoral stem remaining implanted.As of today, device return and additional information has been requested for this revision 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 and did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The supplied medical documents were reviewed.Review of the provided implantation report did not provide and information that could explain the later revision.According to the surgical report, the patient felt fatigued, emotionally labile and had problems with the long-term memory before the revision.During the revision, there was creamy yellowish type of material after opening the fascia and there was clear yellow fluid after opening the joint capsule.Samples were sent for analysis, but result were not provided.It was mentioned that liner showed absolutely no wear, scratches or staining.The available surgical report does not provided details about the diagnosed metallosis.No additional information such as a pathological analysis of tissue from the revision was provided with respect to the diagnosed metallosis.No information related to the reported blood metal ions and psychological symptoms was provided.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 52MM
• 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: 7059797
• MDR Text Key: 92950979
• Report Number: 3005975929-2017-00415
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• 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: Other
• 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: 08/31/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 077787
• 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
• Date Device Manufactured: 08/31/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71291350, LOT # 05EM05141; HEMI HEAD, # 74122546, LOT # 07MW15128; MODULAR SLEEVE, # 74222200, LOT # 07LW14596; STEM SPOUT, # 71291662, LOT # 07EAB0037B
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR