MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT 0 DEG CMT XLPE LNR 36MM X 56MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUS UNCEMENTED

Model Number	71354543
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Post Operative Wound Infection (2446)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presents a postoperative deep infection developed after wound healing disturbance.Prolonged hospitalization ((b)(6) 2018 ¿ (b)(6) 2018).Two complaints were created to cover the shell and the liner.Both are devices that were reported in the clinical event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case from the united states reports a deep infection with wound healing disturbance with the redapt implants.All information available for this complaint case has been reviewed and considered in the medical assessment.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: REDAPT 0 DEG CMT XLPE LNR 36MM X 56MM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLYMER,POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10138971
• Report Number: 1020279-2020-02300
• Device Sequence Number: 2177141
• Product Code: LPH
• UDI-Device Identifier: 00885556323847
• UDI-Public: 00885556323847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 71354543
• Device Catalogue Number: 71354543
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention