MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 ACETABULAR XLPE LINER; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 04/05/2016

Event Type  Injury  

Event Description

It was reported the patient presented with a right hip infection and underwent a right hip irrigation and excisional debridement deep to fascia.Two weeks later (5/19/2016) the patient presented with continued infection and wound drainage and underwent the same procedure again with hematoma evacuation.Per the op notes, there were no gross signs of infection within the joint.The infection was determined to be superficial and therefore the implants were not removed.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.

Event Description

It was reported that, after a right tha revision surgery performed on (b)(6) 2015 (covered under (b)(6)) patient presented intermittent pain, mild erythema, and a crp mildly elevated.On (b)(6) 2016 patient underwent a right hip irrigation, excisional debridement deep to fascia and hematoma evacuation due to a right hip infection (cellulitis) during the surgery it was noticed formed thick and yellow fluid, abundant scar tissue surrounds the cup and neck.Any implant was replaced.Samples were taken from the capsule and intraarticular fibrous tissue and it was found a granulomatous mass superficial to fascia, positive to staphylococcus.Patient outcome is unknown.

• Brand Name: R3 ACETABULAR XLPE LINER
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; 1450 brooks road; memphis, TN 38116 ; 0416283206
• MDR Report Key: 6237597
• MDR Text Key: 64362963
• Report Number: 1020279-2017-00022
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN ACETABULAR SHELL; UNKNOWN FEMORAL HEAD; UNKNOWN STEM; UNKNOWN ACETABULAR SHELL; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female