MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 32 MM 12/14 S / +0; PRSTHSIS,HIP,SMI-CONSTRAIND,METAL/CRAMIC/POLYMRCMNTDORNON-POROUS,UNCMNTD

Catalog Number	76539160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical intervention was performed due to thigh pain and thickening of lateral femoral cortex.The liner, the stem and the head were removed.
Additional Manufacturer Narrative
Additional information: the associated complaint device was not returned for evaluation.Our clinical investigation noted that no patient information has been submitted for review.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Based on the limited information, the root cause of the ¿thigh pain and thickening of lateral femoral cortex at femoral implant tip¿ cannot be concluded but cortical thickening can be a result of micro motion.No information has been forthcoming regarding the current status of this patient.Should any relevant clinical/medical information become available this complaint can be re-assessed.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Without the return of the actual product involved, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: BIOLOX DELTA HEAD 32 MM 12/14 S / +0
• Common Device Name: PRSTHSIS,HIP,SMI-CONSTRAIND,METAL/CRAMIC/POLYMRCMNTDORNON-POROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7279477
• Report Number: 1020279-2018-00198
• Device Sequence Number: 877248
• Product Code: LZO
• UDI-Device Identifier: 03596010566928
• UDI-Public: 03596010566928
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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 Expiration Date: 11/07/2017
• Device Catalogue Number: 76539160
• Device Lot Number: 07LT14323A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/17/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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: Other; Required Intervention