MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 METAL LINER; R3 COCR LINER 56MM

Catalog Number 71341156

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Muscular Rigidity (1968); Skin Discoloration (2074); Skin Discoloration (2074); Injury (2348); Patient Problem/Medical Problem (2688); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 02/10/2017

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed.Skin discolouration and leg stiffness reported.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head, modular sleeve, r3 liner, smf stem and modular neck were removed.The r3 shell 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.Cobalt and chromium levels 3 weeks pre-revision were 11.1 ng/ml and 6.0 ng/ml respectively.A crp was 3.8 mg/l and an x-ray showed a stable implant with no sign of loosening.A ct scan showed a large fluid collection.The revision intraoperative report noted cloudy fluid, corrosion and signs of metallosis type tissue reaction.The pathology report indicated chronic inflammation.The reported elevated c-reactive protein, elevated cobalt and chromium levels and the intraoperative finding of cloudy fluid and corrosion are consistent with findings associated with metallosis; however, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported reactions 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, 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.

Event Description

Left hip revision surgery was performed.Skin discolouration, leg stiffness reported.Ct scan showed fluid collection 5x7cm in pelvis.Elevated test results.

• Brand Name: R3 METAL LINER
• Type of Device: R3 COCR LINER 56MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 8036932
• MDR Text Key: 126065307
• Report Number: 3005975929-2018-00419
• 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
• Report Date: 10/27/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 71341156
• Device Lot Number: 09FW23797
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR