MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PRSTHSIS,HIP,SMICONSTRAIND,MTAL/CRMIC/CRMIC/MTL,CMNTED OR UNCEMENTED

Model Number 71338954

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 08/26/2019

Event Type  Injury  

Event Description

It was reported that the biolox forte ceramic liner was broken.A revision surgery was performed to remove this device.

Manufacturer Narrative

The associated device, used in treatment was not returned.A review of the device information provided indicates that the reported device was part of field action initiated in 2011.It was identified that the manufacturing process completed for several batches of r3 ceramic liners may have created a lower than expected strength for the liners.It is unclear if the device involved in this complaint failed as a result of this previously identified issue as the device was not returned for evaluation.Possible causes could include but not limited to manufacturing process error.Based on this investigation, the need for corrective action was previously implemented.Without clinical documents and the actual device involved, our investigation cannot proceed.No additional actions are being taken at this time.We consider this investigation closed.If the device or new information is received in the future, this complaint 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: PRSTHSIS,HIP,SMICONSTRAIND,MTAL/CRMIC/CRMIC/MTL,CMNTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9861827
• MDR Text Key: 184333186
• Report Number: 1020279-2020-00980
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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 Expiration Date: 06/28/2019
• Device Model Number: 71338954
• Device Catalogue Number: 71338954
• Device Lot Number: 09FT32751
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 11/15/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention