MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71333334
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that revision surgery was performed.The woman had a competitor depuy stem in and fractured her femur.She had a proximal femur procedure and dr.Removed a reflection xlpe size e (32 i.D x 50-52mm) and replaced it with a new one.There was no implant failure of the liner.No more information is available.
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 this complaint from the united states reports a broken femur and a combination of components from different manufacturers.Several attempts have been made to obtain clinical/medical documents to no avail.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 and assessed for any necessary corrective actions.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 risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of the event could include improper sizing or traumatic event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: REF XLPE 32 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9104564
• Report Number: 1020279-2019-03453
• Device Sequence Number: 11243817
• Product Code: JDI
• UDI-Device Identifier: 03596010455673
• UDI-Public: 03596010455673
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71333334
• Device Catalogue Number: 71333334
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1