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

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 08/21/2018

Event Type  Injury  

Event Description

It was reported that a left hip revision surgery was performed due to pain, minimal metallosis and mechanical complication.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the r3 shell, r3 liner, hemi head, modular sleeve and 30mm screws were removed.The stem remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the r3 shell, r3 liner, hemi head, modular sleeve and 30mm screws (08dt18951 & 10jt46077) was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the r3 shell, r3 liner, hemi head and 30mm screw from batch 10jt46077.Similar complaints have been identified for the modular sleeve and 30mm screw from batch 08dt18951.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the 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.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.It cannot be determined to what extent the patients co-morbidities had on her pain and clinical status as well as the anteverted position of the acetabular cup.The reported elevated cobalt and chromium as well as intraoperative findings of the presence of synovial fluid and mild metallosis may be consistent with findings of metal debris and synovitis, however changes in position of the acetabular cup could also accelerate wear and lead to metal debris.Without the supporting pathology results, imaging, and/or explanted components, the root cause of the anteverted position of the acetabular cup, metal debris and synovitis cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 CV31 3HL; UK CV31 3HL
• MDR Report Key: 9528633
• MDR Text Key: 173172678
• Report Number: 3005975929-2019-00454
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Catalogue Number: 71341156
• Device Lot Number: 08FW17416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL 71338667/ (B)(6).; ANTHOLOGY STEM 71356006/ (B)(6).; HEAD SCREW 71332530/ (B)(6).; HEMI HEAD 74122544/ (B)(6).; MODULAR SLEEVE 74222100/ (B)(6).
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR