MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA {} SO STEM SZ 15; PROTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED MET/POLY NON-POROUS, CALICUM-PHOSPH

Catalog Number	71309015
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The primary procedure was done without adverse incidents, using postero lateral approach.However in the ward post-op, the patient dislocated anteriorly the evening of the same day.The surgeon booked a revision for the next day.The stem was revised to a larger stem with less anteversion.The patient is now stable.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no clinical supporting documents were provided to conduct a thorough analysis of the reported issue.No medical assessment can be rendered.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: SYN POR PLUS HA {} SO STEM SZ 15
• Common Device Name: PROTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED MET/POLY NON-POROUS, CALICUM-PHOSPH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489372
• Report Number: 1020279-2018-00862
• Device Sequence Number: 160399
• Product Code: MEH
• UDI-Device Identifier: 03596010459701
• UDI-Public: 03596010459701
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K002996
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: Lay User/Patient
• Device Catalogue Number: 71309015
• Device Lot Number: 13BM02866
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/05/2018
• Supplement Report FDA Received Date: 06/12/2018
• 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