MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVD MONO STEM 240MM SZ 15 HO PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71354822

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after medically indicated revision of right total hip performed on (b)(6) 2018, where redapt slvd mono stem 240mm sz 15 ho was implanted, patient experienced draining sinus appreciated about the medial aspect of the incision with significant amount of purulence drainage. Patient denied any pain. It is unknown if or how the adverse event was treated. 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.

• Brand Name: REDAPT SLVD MONO STEM 240MM SZ 15 HO
• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12524242
• MDR Text Key: 273078131
• Report Number: 1020279-2021-07128
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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

• Device Model Number: 71354822
• Device Catalogue Number: 71354822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/22/2021
• 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 Treatment Data

Date Received: 09/24/2021 Patient Sequence Number: 1