MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 36 20 ANT +4 62-64 H; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333447
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a poly was revised due to unknown reasons.No more information provided yet.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Insufficient information.There is not yet enough information available to classify the health impact.Insufficient information.Health effect appears to have occurred but there is not yet enough information available to classify the clinical signs, symptoms and conditions.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: REF XLPE 36 20 ANT +4 62-64 H
• 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: 8914948
• Report Number: 1020279-2019-03094
• Device Sequence Number: 10894020
• Product Code: LPH
• UDI-Device Identifier: 03596010482822
• UDI-Public: 03596010482822
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2019

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 Expiration Date: 03/16/2019
• Device Catalogue Number: 71333447
• Device Lot Number: 09CM13569
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 11/23/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 12/01/2019
• 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
• Patient Age: 72 YR