MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS CALIPER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 114943

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Event Description

It was reported that during total knee arthroplasty it was noticed that the measurement values on the genesis caliper cannot be read.There was a delay less than or equal to 30 minutes.The procedure was finished using the same device.No injury reported.

Manufacturer Narrative

Task completed.

• Brand Name: GENESIS CALIPER
• 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: 10982941
• MDR Text Key: 220658311
• Report Number: 1020279-2020-07331
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010051219
• UDI-Public: 03596010051219
• 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: 04/29/2021

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: 114943
• Device Catalogue Number: 114943
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1