MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT FULLY POROUS SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71354234
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to infection.A new non-readapt polar cup was implanted so the subject is no longer enrolled in the study.There is no confirmation that the other devices were from smith and nephew.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no medical records have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.When notification has been made that all medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Infection is a complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a 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 warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: REDAPT FULLY POROUS SHELL 58MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9598468
• Report Number: 1020279-2020-00298
• Device Sequence Number: 19626819
• Product Code: LPH
• UDI-Device Identifier: 00885556321447
• UDI-Public: 00885556321447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: Health Professional
• Device Expiration Date: 12/14/2025
• Device Model Number: 71354234
• Device Catalogue Number: 71354234
• Device Lot Number: 15MM12810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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
• Patient Weight: 45