MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO REV STEM 240MM SZ14 SO; PROSTHSIS,HIP,SMI-CONSTRAIND,METAL/CRAMIC/POLYMR,CMNTDORNON-POROUS,UNCMNTD

Catalog Number	71354703
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Limited Mobility Of The Implanted Joint (2671)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to a subsided stem.The stem was removed and replaced.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, based on the lack of clinical/medical information, the root cause of this patients ¿loosening/subsidence¿ cannot be concluded.The cause may have been as the physician suggested the cancer and chemo therapy.Should any relevant information become available this complaint can be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed prior complaints for the listed batch.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.

• Brand Name: REDAPT SLVLS MONO REV STEM 240MM SZ14 SO
• Common Device Name: PROSTHSIS,HIP,SMI-CONSTRAIND,METAL/CRAMIC/POLYMR,CMNTDORNON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7279365
• Report Number: 1020279-2018-00186
• Device Sequence Number: 1211619
• Product Code: LZO
• UDI-Device Identifier: 00885556579282
• UDI-Public: 00885556579282
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 01/16/2026
• Device Catalogue Number: 71354703
• Device Lot Number: 15GTM0002N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/17/2018
• Supplement Report FDA Received Date: 04/17/2018
• 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: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 66