MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 5-6 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420782
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka procedure, the genesis ii dished ins size 5-6 13mm did not get affixed after inserting.Instruments were inside the patient.Procedure was completed with a backup device.There was a slightly delay of less or equal to 30mins.
Additional Manufacturer Narrative
The device, used in treatment, was not received for evaluation and the reported event could not be confirmed.The shipping information was provided and 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.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.Possible causes could include but not limited to fit/sizing issue or poor insertion 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: GII DISHED INS SZ 5-6 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11627491
• Report Number: 1020279-2021-02773
• Device Sequence Number: 11583142
• Product Code: JWH
• UDI-Device Identifier: 03596010209405
• UDI-Public: 03596010209405
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71420782
• Device Catalogue Number: 71420782
• Device Lot Number: 17LM06356
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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: Hospitalization; Other; Required Intervention