MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 74027282

Device Problem Connection Problem (2900)

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

Event Date 05/11/2021

Event Type  Injury  

Event Description

It was reported that, during a tka, surgeon could not get a jrny ii bcs xlpe art isrt sz 7-8 lt 10mm to seat into tibia base, so was opened another identical insert and this also could not be seated into tibial base, finally was opened a constrained insert of same size and insert seated perfectly.Device outside the patient.The procedure was completed without delay with a change in surgical technique.Patient was not harmed.

Manufacturer Narrative

H6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms damage to the lock detail, more than likely due to trying to force the insert to lock into the base-plate.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 LT 10MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11887255
• MDR Text Key: 252728283
• Report Number: 1020279-2021-04691
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556178362
• UDI-Public: 00885556178362
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 74027282
• Device Catalogue Number: 74027282
• Device Lot Number: 20HM08092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 08/03/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention