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
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11057980
• Report Number: 1020279-2020-07717
• Device Sequence Number: 3310833
• Product Code: JWH
• UDI-Device Identifier: 00885556056233
• UDI-Public: 885556056233
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71932634
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other