MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 LEFT; PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED

Catalog Number 71420134

Device Problem Material Fragmentation (1261)

Patient Problems Injury (2348); Radiation Exposure, Unintended (3164)

Event Date 09/07/2018

Event Type  Injury  

Event Description

It was reported that the patient presented with severe wear and metal debris noted on x-rays.

Manufacturer Narrative

The associated complaint device was not returned.A clinical evaluation was conducted and no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of complaint history for the listed part revealed prior complaints for the listed failure mode.The lot is unknown for this device.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: GII OXINIUM FEM SIZE 4 LEFT
• Type of Device: PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7931895
• MDR Text Key: 122614888
• Report Number: 1020279-2018-01896
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010430144
• UDI-Public: 03596010430144
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 71420134
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention