MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE SIZE 4 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	00584202408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during procedure, while trialing zuk insert trial size 4 8 mm, device broke.Procedure was completed with the same device and no delay was reported.The patient was not harmed beyond the described event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it was reported neither the requested operative report, x-rays, patient info or photos would not be provided for inclusion in this medical investigation.However, it was reported the broken device was thrown away, and everything was recovered.Based on the information provided, the procedure was completed with the same device without a delay.Since no harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint will be re-assessed.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.A potential probable cause for this event could include but not limited to surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: ARTICULAR SURFACE SIZE 4 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11187856
• Report Number: 1020279-2021-00448
• Device Sequence Number: 19728657
• Product Code: HSX
• UDI-Device Identifier: 00885556620151
• UDI-Public: 00885556620151
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033363
• 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 Model Number: 00584202408
• Device Catalogue Number: 00584202408
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 01/18/2021
• 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: Required Intervention