MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71440145

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2020

Event Type  malfunction  

Event Description

It was reported that a genesis ii posterior stabilized constrained housing reamer dome exhibit signs of tear and wear from use.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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 no malfunction happened, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.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 P/S CONS HOUSING REAM DOME
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10155111
• MDR Text Key: 195168463
• Report Number: 1020279-2020-02399
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010471338
• UDI-Public: 03596010471338
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440145
• Device Catalogue Number: 71440145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1