MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID US COCR LNR 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341156

Device Problems Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Toxicity (2333); Osteolysis (2377); Test Result (2695)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pseudotumour, elevated metal ion levels, armd and metallosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the r3 liner, hemi head and sleeve were removed.The r3 shell, threaded hole cover and 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.Three months post implantation it was noted that the patient engaged in strenuous athletic activity.Cobalt and chromium levels 4 months pre-revision were 7.8 and 5.6 ppb respectively.The revision intraoperative report indicated turbid yellowish grayish fluid, very dark grayish blackish fluid and solid tissue at the superior aspect.There was osteolysis around the proximal femur and a small area of weakened bone on the acetabular side.The early strenuous and ongoing patient physical activity cannot be ruled out as contributing factors to the reported metallosis and elevated metal ion levels.The reported pain, elevated cobalt and chromium levels and intraoperative findings of black debris around the acetabulum, osteolysis and erosion to the bone are consistent with metallosis.However, without imaging and the explant for analysis, the root cause of the reported reactions cannot be confirmed, and it cannot be concluded that the reported clinical reactions are 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.

• Brand Name: R3 44MM ID US COCR LNR 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 8043256
• MDR Text Key: 126295626
• Report Number: 3005975929-2018-00409
• 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: 11/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71341156
• Date Manufacturer Received: 10/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71331950/R3 3 HOLE HA CTD ACET SHELL 50MM; 74122550/HEMI HEAD 50MM; 74222100/MODULAR SLEEVE -4M; 75002758/PLUS SL STEM LAT 5; 71331950/R3 3 HOLE HA CTD ACET SHELL 50MM; 74122550/HEMI HEAD 50MM; 74222100/MODULAR SLEEVE -4M; 75002758/PLUS SL STEM LAT 5
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR