MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PRSTHSS,HP,SMCNSTRND,MTLCRMCCRMCMTL,CMNTD OR UNCEMENTED

Catalog Number	71338954
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to fractured liner.Head and liner were explanted.
Additional Manufacturer Narrative
The associated r3 ceramic liner, ceramic head and liner ring were returned and evaluated.A lab analysis conducted during this investigation noted the ceramic liner fragment showed metal transfer, chips, and a crack.Scratches and diminished finish was observed on the liner¿s titanium ring.The ceramic femoral head showed diminished polish, chips, scratches, and areas of metal transfer on the articular surface as well as the edges near the female taper.However, the cause of the ceramic liner fracture could not be determined in this investigation.The ceramic liner was manufactured in 2009.Our investigation indicated that the related device was part of field action initiated in 2011.Corrective actions have been initiated.The r3 ceramic liner has been obsoleted and is no longer available for purchasing.A clinical analysis noted that no relevant supporting documentation was provided for inclusion in this medical investigation.It was reported that the surgeon did not fault the component.Based on the limited information provided, the root cause of the liner fracture which led to the subsequent revision tha cannot be concluded.The patient impact beyond the reported symptoms and hip head and liner revision cannot be determined.No further medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Common Device Name: PRSTHSS,HP,SMCNSTRND,MTLCRMCCRMCMTL,CMNTD OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7563203
• Report Number: 1020279-2018-01025
• Device Sequence Number: 18876649
• Product Code: MRA
• UDI-Device Identifier: 00885556021927
• UDI-Public: 00885556021927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 71338954
• Device Lot Number: 09BT29050
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention