MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX DELTA HEAD 36 MM 12/14 M / +4; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED/UNCEMENTED

Catalog Number	76539166
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery due to a fall at a nursing facility two weeks post operation and resulted in a peri prosthetic fracture that required the explantation of the femoral head implant.
Additional Manufacturer Narrative
Investigation results: the associated complaint devices were not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Without the explant or the requested clinical information, the root cause of the peri prosthetic fracture cannot be determined.The future impact to the patient cannot be determined due to the lack of clinical information.No further clinical/medical assessment is warranted at this time.

• Brand Name: BIOLOX DELTA HEAD 36 MM 12/14 M / +4
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/POLYMER,CEMENTED/UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7227913
• Report Number: 1020279-2018-00094
• Device Sequence Number: 1185425
• Product Code: LZO
• UDI-Device Identifier: 03596010566966
• UDI-Public: 03596010566966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 76539166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2018
• Supplement Date Received by Manufacturer: 01/20/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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: Death; Hospitalization; Required Intervention