MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Catalog Number	71338952
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal.It was reported that a patient underwent medically indicated revision of the r3 system left hip on (b)(6) 2020.The patient revision surgery was performed due to a fractured r3 ceramic liner.The patient outcome is unknown.
Additional Manufacturer Narrative
Additional information received identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.The (b)(4) was found to be a duplicate of the (b)(4) (related to (b)(4)) therefore the (b)(4) will be closed.The current investigation will be discarded.The correct investigation and findings will be performed under the (b)(4) (related to (b)(4)).

• Brand Name: R3 36MM ID US CRMC LINER 52MM
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11568083
• Report Number: 1020279-2021-02363
• Device Sequence Number: 19697971
• Product Code: MRA
• UDI-Device Identifier: 00885556021552
• UDI-Public: 885556021552
• Combination Product (Y/N): N
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 04/28/2019
• Device Catalogue Number: 71338952
• Device Lot Number: 09DT30733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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; Other; Required Intervention