MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PROSTHESIS HIP SEMI-CONSTRAINED CERAMICMETAL CEMENTED OR UNCEMENTED

Catalog Number	71338954
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Liner and head were removed and replaced in a revision surgery.Ceramic liner broke into 3 pieces.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A lab analysis indicated gray to black markings observed on the articular surface.Additional marking were found on the lower face and inside the taper.It is likely these are signs of metal transfer.No other observations made concerning femoral head.The ceramic liner found to be fractured into three pieces of various sizes.The larger fragment remains in contact with the supporting metal band.The second largest fragment covered most of the apex of the liner id while the third broke out from the side.Metal transfer was observed on the articular surface of the second fragment.Metal transfer was also observed on the face of the larger fragment opposite the fractured area of the third fragment.A portion of the id also exhibited metal transfer.No other observation was made during this investigation.A clinical analysis indicated that it was reported that a revision was performed due to the r3 ceramic liner breaking.There are no details regarding the reported incident.There have been three attempts to obtain relevant patient clinical/medical data, however no information has been provided.The explanted devices were returned and evaluated, however the cause of the ceramic liner fracture could not be determined.A thorough clinical analysis is not able to be rendered based on the limited clinical details provided.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this complaint closed.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Common Device Name: PROSTHESIS HIP SEMI-CONSTRAINED CERAMICMETAL CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7279442
• Report Number: 1020279-2018-00191
• Device Sequence Number: 19144842
• Product Code: MRA
• UDI-Device Identifier: 00885556021927
• UDI-Public: 00885556021927
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 05/22/2018

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: No Information
• Device Catalogue Number: 71338954
• Device Lot Number: 09FT33140
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/17/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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