MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE HA CTD ACET SHELL 58MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71332258

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/04/2019

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to an infection of pseudomonas.An exeter and all poly cup were re-implanted with copal antibiotic cement.No operative reports are available.

Manufacturer Narrative

It was reported that a revision surgery was performed due to an infection of pseudomonas.An exeter and all poly cup were re-implanted with copal antibiotic cement.The affected r3 delta ceramic liner and r3 acetabular shell, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.No relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.The reported failure has been noted on the instructions for use and on the risk management files.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 0 HOLE HA CTD ACET SHELL 58MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9532897
• MDR Text Key: 173168894
• Report Number: 1020279-2019-04695
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332258
• Device Lot Number: 18EM07959
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention