MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 32 MM 12/14 S / +0; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT

Model Number	76539160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a revision surgery was performed due to a proximal femur periprosthetic fracture.The entire femoral component was revised.The outcome is resolved.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this clinical study case reports that a revision was performed due to a proximal femur periprosthetic fracture, revising the entire femoral component.To date, the requested patient records and x-rays have not been provided to fully evaluate the root cause of the reported event.Without clinically relevant patient-specific supporting documentation a thorough medical investigation cannot be rendered.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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 risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to excessive forces applied to implant and inadequate design.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.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: PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11449628
• Report Number: 1020279-2021-01920
• Device Sequence Number: 14333379
• Product Code: LZO
• UDI-Device Identifier: 03596010566928
• UDI-Public: 03596010566928
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 76539160
• Device Catalogue Number: 76539160
• Device Lot Number: 19DT20332
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64