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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient for unspecified reasons.Cup, liner and head exchanged.No procedure details available.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that no clinically relevant supporting documentation was provided; therefore, a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.Without the actual product involved and/or device information, 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: 8683219
• Report Number: 1020279-2019-02242
• Device Sequence Number: 2259867
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 08MT27178
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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