MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC PRI SPACER BLOCK; PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER

Model Number 71441265

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, the white o rings are gone and device would not hold on clip on build ups.There was no delay and no injury.It's unknown how the procedure concluded.

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during surgery, it was noticed that the white o rings were gone and the device would not hold on clip on build ups.There was no delay and no injury.It's unknown how the procedure concluded.However after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since this event did not cause any injury and it would not be likely to cause or contribute to a death or serious injury that if the device malfunction were to recur.

• Brand Name: GII SPC PRI SPACER BLOCK
• Type of Device: PRSTHSS,KNEE,FEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10558491
• MDR Text Key: 207698201
• Report Number: 1020279-2020-04742
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556034354
• UDI-Public: 00885556034354
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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: 71441265
• Device Catalogue Number: 71441265
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1