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

Catalog Number 74120144

Device Problems Metal Shedding Debris (1804); Patient Device Interaction Problem (4001)

Patient Problems Complaint, Ill-Defined (2331); Arthralgia (2355); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 06/23/2017

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to hip pain and other complications.Operative notes reportedly describe metallosis and a pseudotumor in hip joint.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain and other complications.As of today, device return and additional information has been requested for this complaint but has not become available.The device batch/lot details have not been received therefor no thorough manufacturing record review and assessment of the reported event can be performed.The available medical documents were reviewed.According to the provided implant report, the stem was placed 2 to 3 mm deeper than the neck cut.According to the provided revision report, there was a large amount of fluid below the fascia and extracapsular within the pseudocapsule.The diagnosis was metallosis with lysis and greater trochanter fracture.The latter was treated with an internal fixation.The morse taper was described in good condition and the stem remained in-vivo.Whether there is a relation between placing the stem deeper than the neck cut and the reported finding cannot be assessed based on the provided information.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.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup, hemi head and modular sleeve were removed.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 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.The intraoperative findings of metallosis, osteolysis, and elevated metal ions are consistent with findings associated with metal debris.The patient¿s history of both dysplastic hip syndrome and chronic steroid injections, may have been a contributing factor in her poor bone quality.Without all supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of the reported clinical reactions cannot be confirmed, and it cannot be concluded that they were associated with a mal-performance of the implant.Additionally, the use of a zimmer acetabular component with a smith + nephew implant, which is contraindicated, and cannot be ruled out as a contributing factor.It cannot be concluded that the reported reactions/events were associated with a mal-performance of the smith + nephew 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: BHR ACETABULAR CUP
• 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: 7457556
• MDR Text Key: 106395050
• Report Number: 3005975929-2018-00135
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 74120144
• Device Lot Number: 51270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2018
• Patient Sequence Number: 1
• Treatment: 74122538, LOT 10003; 74222200, LOT 11042; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR