MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71932634

Device Problem Device Fell (4014)

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

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported that, during a tka procedure, the gen ii 7.5mm resur pat 26mm patella fell off of the cement that had adhered to the patient's native patella.The procedure was successfully completed using a back-up device.It is unknown if there was any delay in the procedure.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not received for evaluation and the reported event could not be confirmed.All efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.The clinical/medical investigation concluded that, this case reports that after removing the patella cement clamp, the patella completely fell off of the cement that had adhered to the patient's native patella.Per the sales rep, a new/backup patella was opened and implanted.There was no patient harm reported, however it is unknown whether there was surgical delay.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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.Possible probable cause could include but not limited to procedural variance, product preparation or storage condition.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: GEN II 7.5MM RESUR PAT 26MM
• 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: 11057980
• MDR Text Key: 223210868
• Report Number: 1020279-2020-07717
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556056233
• UDI-Public: 885556056233
• Combination Product (y/n): N
• 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: 08/23/2021

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 Catalogue Number: 71932634
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other