MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 50MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,MTL/CRMC/CRMIC/METAL, CEMENTED OR UNCEMENTED

Catalog Number 71335550

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/10/2018

Event Type  Injury  

Event Description

It was reported that patient had an mri performed and received an epidural steroid shot due to pain and numbness in knee.Doctor relates it to the hip prosthesis.

Manufacturer Narrative

The affected r3 3hole acetabular shell, r3 0 deg acetabular liner and reflection spherical head screws were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Therefore, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batches which did not reveal any deviation from the standard manufacturing processes.Our clinical evaluation noted that the patient¿s complaint of vision problems relating to either titanium toxicity or lt tha metallosis cannot be determined and is not supported by the multiple clinical visits nor the provided lab values which don¿t include metal ion levels.There is no supporting clinical documentation to draw a causal relationship with the reported symptoms and the device.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however 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.

• Brand Name: R3 3 HOLE ACET SHELL 50MM
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,MTL/CRMC/CRMIC/METAL, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 8167751
• MDR Text Key: 130459811
• Report Number: 1020279-2018-02797
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010598233
• UDI-Public: 03596010598233
• Combination Product (y/n): N
• PMA/PMN Number: P030022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Catalogue Number: 71335550
• Device Lot Number: 11HM09036
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other