MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN REDAPT MONOBLOCK STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNKN01100102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after a medically indicated conversion of previous left hip surgery to total hip arthroplasty to repair a non union performed on (b)(6) 2015, where redapt modular slvd stem 240mm sz 19 was implanted, the patient experienced draining wound at distal aspect of hip incision.The wound was warm on touch and the patient had an infected picc line confirmed on blood test.An incision and drainage of a wound was planned 6 weeks after the surgery, but no confirmation was received.The patient continued having the draining wound and an overwhelming infection was reported 3 months postop.Device explantation was indicated, however a revision surgery was not confirmed.Additional details about primary surgery are unknown.Patient outcome is unknown.This de-identified clinical data is related to a post market clinical follow-up activity for redapt sleeved mono stems.As the data collection activity has been done retrospectively and data is provided anonymized, the information provided is limited and further information cannot be obtained.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the post market clinical follow-up was anonymous.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided this complaint will be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN REDAPT MONOBLOCK STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12524232
• MDR Text Key: 273078579
• Report Number: 1020279-2021-07126
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01100102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71354219/REDAPT MOD SLEEVE 18-19 XS GRIT
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR