MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7.0MM O.D. WASHER; PLATE, FIXATION, BONE

Catalog Number	71143107
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Presented to the ed on (b)(6) with right knee pain that had started 3 days prior to seeking help.Removal of deep hardware right knee (3.5 cortical screw x 1), arthroscopic right knee lavage for drainage of septic arthritis, arthroscopic right knee removal of foreign body (retained intra-articular screw washer), arthroscopic right knee complete synovectomy, findings - significant arthrosis medial compartment with large defect, from intra-articular screw tract, gross purulence noted in knee.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical medical team concluded, this complaint is from a retrospective study in (b)(6) and identified during data cleaning in (b)(6) 2018.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: 7.0MM O.D. WASHER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7632769
• Report Number: 1020279-2018-01185
• Device Sequence Number: 1788374
• Product Code: HRS
• UDI-Device Identifier: 03596010387356
• UDI-Public: 03596010387356
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2018

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: Physician
• Device Catalogue Number: 71143107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 09/03/2018
• 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
• Patient Age: 53 YR
• Patient Weight: 121