MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71441137

Device Problem Defective Device (2588)

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

Event Date 08/26/2020

Event Type  malfunction  

Event Description

It was reported that during tka a pin stuck in the cutting block.It is unknown how the procedure finished.Unknown if occurred a surgical delay.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: GII MI IN SLT 3 MO TI CU BL RT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 10563856
• MDR Text Key: 207832885
• Report Number: 1020279-2020-04754
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010484093
• UDI-Public: 03596010484093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: 71441137
• Device Catalogue Number: 71441137
• Device Lot Number: 16EM00190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1