MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIGH OFFSET NEUTRAL MODULAR NECK; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	71352112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.Mechanical fall secondary to etoh (alcohol), fell on right side, causing periprosthetic fracture.Subject had femoral stem, femoral head and femoral neck revised.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of the complaint history for the listed parts revealed no prior complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Our clinical/medical team concluded: based on the surgeon¿s statement provided, the root cause of the periprosthetic fracture was due to the patient¿s intoxication, trip and fall on her right side.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the actual products involved, 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: HIGH OFFSET NEUTRAL MODULAR NECK
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7875135
• Report Number: 1020279-2018-01808
• Device Sequence Number: 184713
• Product Code: JDH
• UDI-Device Identifier: 03596010619549
• UDI-Public: 03596010619549
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 71352112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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