MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 5; PRSTHSISKNEEPTLLOFMROTIBLSMICNSTRINDCMNTDPLYMRMTLPOLYMR

Catalog Number	71421115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery performed on 2016.It was reported that on (b)(6) 2018 patient felt an unusual sensation when standing up from a seated position, the joint felt loose and had a clicking noise.Patient knee and lower leg started to swell and pain increased.A scan was performed at (b)(6) hospital, where they diagnosed a burst bakers cyst.In (b)(6), patient contacted her surgeon; a joint x-ray was performed, doctor diagnosed a broken and displaced insert.A revision surgery was performed to correct the issue.During the operation it was discovered that the post on the insert had sheared off and the metal parts had worn on each other leaving significant metallic debris around the joint and metallosis.Since then, the second knee has taken much longer to recover and patient still needs the aid of crutches to walk significant distances and requires the nightly use of diclofenac 3% gel.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already reported on mdr, case no: 1020279-2019-00804, therefore, it was determined that this case does not meet the threshold for reporting.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII OXIN P/S FEM RIGHT SZ 5
• Common Device Name: PRSTHSISKNEEPTLLOFMROTIBLSMICNSTRINDCMNTDPLYMRMTLPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9482275
• Report Number: 1020279-2019-04438
• Device Sequence Number: 4130311
• Product Code: JWH
• UDI-Device Identifier: 03596010469298
• UDI-Public: 03596010469298
• Combination Product (Y/N): N
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71421115
• Device Lot Number: 15LM15807
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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