MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID US COCR LNR 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341150

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 02/28/2017

Event Type  Injury  

Event Description

It was reported a revision surgery from the right hip was performed due to severe pain, elevated cobalt levels, pseudotumor, loss of soft tissue, abductor weakness, ongoing pain and suffering, and limited mobility.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head, sleeve and r3 metal liner were removed.The synergy stem, r3 shell, threaded hole cover and screw 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.The patient has a history of several orthopaedic comorbidities.The patient had bilateral hip and knee arthroplasties.History of degenerative disease to the lumbar spine with radiating pain to bilateral lower extremities, status post two low back surgeries.History of peripheral neuropathy, rls, pain control issues and polysubstance abuse.She used illegal drugs in the past including meth as well as cocaine and admitted to getting narcotics off the street.She is a truck driver and got into an accident on her job (b)(6) 2009.The implantation op report noted steroid induced avn of the right proximal femur.Intraoperative visual exam and post implantation x-rays indicate the acetabular portion of the arthroplasty in usual position.It was also noted she had a little bit of uncoverage superior and posterior but excellent fixation and a single screw was placed superiorly for added stability.Cobalt and chromium levels 2 months pre-revision were >100 mcg/l and 48.3 mcg/l respectively.A revision was performed in 2017, the cup and stem remained in situ.The revision operative report indicated a large pseudotumor, stained black tissue, metal debris creating an osteolysis and the acetabular liner anteversion was slightly elevated.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion.It should be noted bhr is contraindicated for avascular necrosis with >50% involvement of the femoral head.Bhr is also contraindicated for persons receiving high doses of corticosteroids.It cannot be determined to what extent the patient¿s medical history, acetabular position, work related accident and drug abuse impacted her pain and clinical reactions.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the metal debris and black tissue noted intraoperatively.Without the supporting lab/pathology results or relevant imaging, the root cause of the reported elevated metal ions, pain, pseudotumor, and intraoperative findings of black tissue and metal debris cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.However, based on the available information, the suggested root cause for the revision would be an adverse incident due to either the accident at the patient¿s job or the use of multiple illegal drugs.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: R3 38MM ID US COCR LNR 50MM
• 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: 8137734
• MDR Text Key: 129476913
• Report Number: 3005975929-2018-00529
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 71341150
• Device Lot Number: 08FW17395
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD SCREW 71332525 LOT 09DT30753; HOLE COVER 71336500 LOT 09DM06308; MODULAR SLEEVE 74222200 LOT 08CW16020; R3 LINER 71335550 LOT 08LM07278; R3 SHELL 71335550 LOT 08LM07278; SYN POR FEM 71306615 LOT 08KM10897; HEAD SCREW 71332525 LOT 09DT30753; HOLE COVER 71336500 LOT 09DM06308; MODULAR SLEEVE 74222200 LOT 08CW16020; R3 LINER 71335550 LOT 08LM07278; SYN POR FEM 71306615 LOT 08KM10897
• Patient Outcome(s): Hospitalization; Required Intervention