MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441152

Device Problem Component Missing (2306)

Patient Problem Injury (2348)

Event Date 05/28/2020

Event Type  Injury  

Event Description

It was reported that after procedure tka the surgeon did not notice the missing peg from the cutting block until postoperative x-ray (during the procedure the surgeon followed proper technique in placement and removal of the 4 in 1 cutting block).The procedure was completed without delay.

Manufacturer Narrative

Additional information based on the results of the investigation indicates that this complaint should be reassessed in terms of reportability.The new information reveals that the device corresponding to this complaint belongs to a different set of devices than the one initially reported and also does not present any failure related to the reported event.

• Brand Name: GII MIS DCF AP CT BLK 4
• 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: 10176726
• MDR Text Key: 195894542
• Report Number: 1020279-2020-02623
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010497208
• UDI-Public: 03596010497208
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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
• Device Operator: Health Professional
• Device Model Number: 71441152
• Device Catalogue Number: 71441152
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention