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
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Injury (2348); Radiation Exposure, Unintended (3164)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with severe wear and metal debris noted on x-rays.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2018-01896
• Device Sequence Number: 1998622
• Product Code: LZO
• UDI-Device Identifier: 03596010430144
• UDI-Public: 03596010430144
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71420134
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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