MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S1-2 15M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number 71421534

Device Problems Fracture (1260); Pitted (1460); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Bone Shedding Debris (4557)

Event Date 04/08/2021

Event Type  Injury  

Event Description

It was reported that during a tka revision surgery the genesis ii cr deep flex insert s1-2 15m was pitted and worn, the knee capsule had poly debris in it when opened.The implant was extracted and replaced with a dished cr insert; therefore, the procedure had to be finished changing the surgical technique.Furthermore, the patient was not injured beyond the described event.No other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the worn and pitted device was confirmed.The clinical/medical investigation concluded that, the requested clinical documentation was not available for inclusion in the medical investigation.Without the x-rays, operative reports and explant for evaluation, the clinical root cause could not be definitively concluded.The provided intra-op image of the explanted insert supports the ¿pitted and worn¿ complaint.Reportedly, the ¿capsule had poly debris in it when opened¿ and a dished cr insert was implanted; ¿ therefore, the procedure had to be finished changing the surgical technique¿.Patient impact beyond the reported poly wear, poly debris, and revision with a change in the surgical technique could not be determined.No further complications were reported.No further assessment can be rendered at this time.Should clinically relevant documentation/information and/or product evaluation findings become available, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Potential causes could include but are not limited to friction, joint tightness or lifetime of device.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII CR DEEP FLEX ISRT S1-2 15M
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11777471
• MDR Text Key: 249055548
• Report Number: 1020279-2021-03745
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010520333
• UDI-Public: 03596010520333
• Combination Product (y/n): N
• PMA/PMN Number: K041825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 71421534
• Device Catalogue Number: 71421534
• Device Lot Number: 06MM10484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention