MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 US COCR LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120150

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Diarrhea (1811); Emotional Changes (1831); Hearing Loss (1882); Pain (1994); Tinnitus (2103); Visual Impairment (2138); Vomiting (2144); Tingling (2171); Toxicity (2333); Injury (2348); Depression (2361); No Information (3190)

Event Date 01/10/2019

Event Type  Injury  

Event Description

Patient submitted medwatch mw5086994 reports left hip revision surgery due to metal toxicity and dislocation.Patient reported the following symptoms from 2015.Pain, popping and clunking in joint, extreme depression, mood swings, tingling in hands and feet, ringing in ears, vision and hearing loss, vomitting, diarrhea, early onset of menopause.2017 10 day admittance to psych ward in hospital.

Manufacturer Narrative

As of today, device return and additional information has been requested for this complaint but has not become available.Since neither the underlying medical documents nor device part details were received for investigation no thorough medical investigation, manufacturing record review and assessment of the reported event can be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.If the products or additional information become available in the future, this case will be reopened.Without additional information about this patient¿s particular case, our investigation remains inconclusive.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 US COCR LINER
• 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: 8702876
• MDR Text Key: 148130877
• Report Number: 3005975929-2019-00246
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74120150
• Device Lot Number: 087276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN.; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention