MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71331854
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 r3 0 hole acetabular shell and reflection threaded hole cover were not returned for evaluation.Therefore, a product evaluation could not be conducted.A clinical analysis was performed 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.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.We will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) 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.Approved by justin templeton md on may 30, 2019.

• Brand Name: R3 0 HOLE ACET SHELL 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: 8209969
• Report Number: 1020279-2019-00012
• Device Sequence Number: 264289
• Product Code: MBL
• UDI-Device Identifier: 03596010597601
• UDI-Public: 03596010597601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• 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
• Report Date (Section B): 06/08/2019

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: 01/21/2018
• Device Catalogue Number: 71331854
• Device Lot Number: 08AM18067
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 06/08/2019
• 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: 71336500 / 09GM15912; (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR