MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY SO POR PL HA SZ 7; PROSTHESIS HIP SEMI-CONSTRAINED METAL/CERAMIC/CERAMIC/METAL CEMENTED/UNCEMENTED

Catalog Number 71357007

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/13/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to unspecified reasons (pain) to remove the stem and cup from the patient.No delay reported.

Manufacturer Narrative

The associated reflection 3 hole shell and anthology porous plus high offset stem were not returned for evaluation.Therefore products evaluation could not be performed.After repeated requests, smith and nephew has been unable to obtain device details.Thus, a review of device history record could not be performed.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Our clinical evaluation noted that no relevant clinical supporting documents were provided to conduct a thorough medical assessment of the reported thigh and groin pain.Should additional relevant clinical information be provided this complaint will be re-assessed.Without the return of the actual product involved and no product information available, 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: ANTHOLOGY SO POR PL HA SZ 7
• Type of Device: PROSTHESIS HIP SEMI-CONSTRAINED METAL/CERAMIC/CERAMIC/METAL CEMENTED/UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8108752
• MDR Text Key: 128558393
• Report Number: 1020279-2018-02624
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 03596010559623
• UDI-Public: 03596010559623
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71357007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR