MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTH, HIP, SEMI-CONST, METAL/CERAMIC/CERAMIC/METAL, CEMENT OR UNCEMENT

Catalog Number 71338952

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 06/17/2019

Event Type  Injury  

Event Description

It was reported that the doctor revised a shattered an r3 ceramic liner.The head and the liner were removed.A poly liner was implanted.No further information available.

Manufacturer Narrative

The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved 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 52MM
• Type of Device: PROSTH, HIP, SEMI-CONST, METAL/CERAMIC/CERAMIC/METAL, CEMENT OR UNCEMENT
• 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: 8787667
• MDR Text Key: 150957444
• Report Number: 1020279-2019-02669
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00885556021552
• UDI-Public: 00885556021552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO30022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71338952
• Device Lot Number: 09FT53137
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention