MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT MOD SLV MED SZ 12-13 STIKTITEW/HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number 71354041

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

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a thr surgery performed on (b)(6) 2018, the patient presented to hospital with a significant infection and an abscess of his right hip extending distally to approximately 10cm proximal to the knee.This adverse situation was treated with a revision surgery performed on (b)(6) 2021, where the redapt 300mm sleeved revision stem size 13 high offset, the redapt modular sleeve medium size 12-13 stiktite with hydroxyapatite and the biolox delta head 36 mm 12/14 long / +8 were removed.Current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the one undated, unlabeled x-ray photo provided was reviewed, however, the image does not provide any insight into the reported event for conducting a thorough clinical analysis.Should additional relevant supporting x-ray images, lab reports and operative reports become available in the future, this case can be reassessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.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: REDAPT MOD SLV MED SZ 12-13 STIKTITEW/HA
• 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: 12537696
• MDR Text Key: 273540105
• Report Number: 1020279-2021-07203
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00885556023969
• UDI-Public: 00885556023969
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71354041
• Device Catalogue Number: 71354041
• Device Lot Number: 14KM12071A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2014
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR
• Patient Sex: Male