MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF FXD NECK SIZE 2 HO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A clinical evaluation noted that without the requested clinical information, the root cause of the pain cannot be concluded but its relationship to the femoral fracture and stem subsidence cannot be ruled out.The future impact to the patient beyond the revision cannot be concluded.The surgical date for the ltha is still pending.No further clinical/medical assessment is warranted at this time.Our investigation included a review of the manufacturing records which did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for this failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.

• Brand Name: SMF FXD NECK SIZE 2 HO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7323395
• Report Number: 1020279-2018-00284
• Device Sequence Number: 18859461
• Product Code: LPH
• UDI-Device Identifier: 00885556159248
• UDI-Public: 00885556159248
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: 71352703
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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