MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 US DELTA HEAD 32 +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/CERAM/MET, CEMENTED OR UNCEMENTED

Model Number	71325172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery took place on (b)(6) 2021 due to a femoral stem subsided.It was replaced with a bigger implant.Implants removed were r3 us delta head 32 +4 and polarstem collar std.Ti/ha 2.There are no thoughts from the surgeon that the implant failed.He believes it was undersized.Primary surgery took place on (b)(6) 2019.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, primary surgery took place on (b)(6) 2019.It was reported that the femoral stem subsided and the patient had a revision (b)(6) 2021.It was replaced with a bigger implant.¿there are no thoughts from the surgeon that the implant failed.He believes it was undersized.¿ the clinical root cause of the subsidence and subsequent revision is related to the ¿undersized femoral stem and is not related to a malperformance of the implant.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, size of device, lack of ingrowth, lifetime of device, and traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 US DELTA HEAD 32 +4
• 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: 11478943
• Report Number: 1020279-2021-02101
• Device Sequence Number: 3430674
• Product Code: MRA
• UDI-Device Identifier: 00885556499092
• UDI-Public: 00885556499092
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Model Number: 71325172
• Device Catalogue Number: 71325172
• Device Lot Number: 18MT13693
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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