MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Catalog Number 71338954

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 05/20/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient for unspecified reasons.Cup, liner and head exchanged.No procedure details available.

Manufacturer Narrative

The associated complaint device was not returned.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Type of Device: PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8683219
• MDR Text Key: 147471955
• Report Number: 1020279-2019-02242
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556021927
• UDI-Public: 00885556021927
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71338954
• Device Lot Number: 08MT27178
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention