MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS

Catalog Number	71332754
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had persistent pain after revision surgery and an injection intro the trochanteric bursa was given to relief the pain.Also, xrays were done to diagnose the reason of the pain but nothing abnormal was found.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and based on the surgeon¿s statement, ¿there are no obvious signs of loosening.The patient¿s pain is consistent with trochanteric bursitis¿.Since this patient only experienced a 50% relief of pain, this issue is ongoing therefore, the future impact to the patient cannot be determined.No further clinical medical investigation is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with 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.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: R3 0 DEG XLPE ACET LNR 36MM X 54MM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8207403
• Report Number: 1020279-2019-00002
• Device Sequence Number: 2025764
• Product Code: MBL
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2019

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: 12/20/2024
• Device Catalogue Number: 71332754
• Device Lot Number: 14MM01486
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 12/03/2018
• Initial Report FDA Received Date: 01/01/2019
• Supplement Report FDA Received Date: 01/01/2019; 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71331854 / 08AM18067; 71336500 / 09GM15912
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR