MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 13; PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,METAL/POLYMR,NON-PORS,CALICUM-PHSPHAT

Catalog Number 71309113

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 10/25/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to fracture.The femoral head and the stem were explanted and replaced.Delay of less than 30min reported.

Manufacturer Narrative

It was reported that the patient has fractured his medial calcar and his femoral stem has subsided, all due to his size and bulk.This led to his revision and the oxinium femoral head and synergy porous high offset stem were removed.The devices were not made available for evaluation.Therefore products inspection could not be performed.However, device details were provided.Thus, a review of device history record and complaint history were performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints with the same failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical evaluation could not performed at this time as no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.However, based the ct that confirms the calcar fracture and the x-ray showed the stem subsidence.The patient body habitus as a likely contributing factor cannot be ruled out.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SYN POR PLUS HA HO STEM SZ 13
• Type of Device: PRSTHSIS,HIP,SMI-CNSTRND,UNCMNTD,METAL/POLYMR,NON-PORS,CALICUM-PHSPHAT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8075427
• MDR Text Key: 127291606
• Report Number: 1020279-2018-02504
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010459787
• UDI-Public: 03596010459787
• Combination Product (y/n): N
• PMA/PMN Number: K002996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71309113
• Device Lot Number: 17MM01784
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 185