MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Catalog Number	71338954
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to liner fracture.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, the photo and radiology images provided do not indicate a root cause.The fracture could be due to some type of trauma along with wear over the years of the implant.However, in the absence of the relevant supporting documentation, a definitive root cause of the liner fracture cannot be determined.No further clinical assessment is warranted.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/failure mode.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 54
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8559561
• Report Number: 1020279-2019-01691
• Device Sequence Number: 2065850
• 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
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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: 71338954
• Device Lot Number: 09ET32145
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/28/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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