MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,

Model Number 71421029

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/23/2020

Event Type  Injury  

Event Description

It was reported that a patient received a revision left total knee replacement on (b)(6) 2020.Patient has complained of anterior knee pain increasing in severity.A revision surgery was performed on (b)(6) 2020 and the patella bone was resected and new resurfacing patella implanted.Surgeon believed this was 'overstuffed' from x-ray images and patient symptoms.Patient outcome is unknown.

Manufacturer Narrative

It was reported that a revision surgery was performed as patient has complained of anterior knee pain increasing in severity.The patella bone was resected and new resurfacing patella implanted.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A clinical evaluation noted that based on the x-rays/information provided, the reported ¿overstuffing¿ and laterally riding patella were likely the root cause of the reported event.The patient impact beyond the reported increasing pain and subsequent revision procedure could not be determined, as the patient outcome remains unknown.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII OVAL RESURFACING PAT 29MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10850391
• MDR Text Key: 216556449
• Report Number: 1020279-2020-06527
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010485052
• UDI-Public: 03596010485052
• Combination Product (y/n): N
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: Lay User/Patient
• Device Model Number: 71421029
• Device Catalogue Number: 71421029
• Device Lot Number: 19GM04625
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention