MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 32MM ID US CRMC LINER 48; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CEMENTED OR UNCEMENTED

Catalog Number	71338948
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgeon revised r3 ceramic liner due to failure.Liner had fractured in multiple points in load bearing region.After pieces were removed, a new plastic liner was placed in the existing cup.
Additional Manufacturer Narrative
The associated device 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.A clinical analysis indicated that based on the lack of information, the root cause of the ceramic liner breakage cannot be concluded.Should any relevant information become available this complaint can be re-assessed.Without the actual device involved, our investigation cannot proceed.No additional actions are being taken at this time.

• Brand Name: R3 32MM ID US CRMC LINER 48
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7262508
• Report Number: 1020279-2018-00155
• Device Sequence Number: 19128926
• Product Code: MRA
• UDI-Device Identifier: 00885556022047
• UDI-Public: 00885556022047
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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 Catalogue Number: 71338948
• Device Lot Number: 09ET32146
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/10/2018
• Supplement Report FDA Received Date: 04/20/2018
• 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: Required Intervention