MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTH, HIP, SEMI-CONST, METAL/CERAMIC/CERAMIC/METAL, CEMENT OR UNCEMENT

Catalog Number	71338952
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor revised a shattered an r3 ceramic liner.The head and the liner were removed.A poly liner was implanted.No further information available.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.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.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 52MM
• Common Device Name: PROSTH, HIP, SEMI-CONST, METAL/CERAMIC/CERAMIC/METAL, CEMENT OR UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8787667
• Report Number: 1020279-2019-02669
• Device Sequence Number: 11273401
• Product Code: MRA
• UDI-Device Identifier: 00885556021552
• UDI-Public: 00885556021552
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PO30022
• 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): 12/02/2019

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: 71338952
• Device Lot Number: 09FT53137
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/14/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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