MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT PF STEM-240MM SZ 20; PLATE, FIXATION, BONE

Catalog Number	71354320
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/19/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove modular redapt stem due to infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.However, per the case report form, the revision was due to infection; neither the root cause nor organism was identified.The patient impact beyond the reported revision, associated therapies, and discontinued participation in the study could not be determined.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.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.

• Brand Name: REDAPT PF STEM-240MM SZ 20
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8626422
• Report Number: 1020279-2019-01985
• Device Sequence Number: 16669942
• Product Code: HRS
• UDI-Device Identifier: 03596010619532
• UDI-Public: 03596010619532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Catalogue Number: 71354320
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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