MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 3-4 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY

Model Number	71420766
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the procedure (total arthroplasty of the right knee), when the device was placed (3-4, 9mm), it was not possible since the insert didn´t fully enter in the tibial plate.After several attempts to place it, it was necessary to remove it in order to use a device bigger (3-4, 11mm).There was no damage to the patient since the failure device was removed completely and a smith + nephew backup device was used to complete the procedure successfully.There was a delay less than or equal to 30 minutes.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device shows damage to the lock detail, more than likely due to trying to force the insert to lock into the baseplate.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Our clinical/medical team noted: per complaint details, the 9mm insert did not lock into the tibial baseplate.Reportedly, after several attempts, the procedure was completed with a (thicker 11mm insert) backup device without patient injury or harm within a 5 minute surgical extension.Further patient impact would not be anticipated.No further medical assessment is warranted at this time.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but is not limited too, fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
Additional information: d4, h4.H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, the 9mm insert did not lock into the tibial baseplate.Reportedly, after several attempts, the procedure was completed with a (thicker 11mm insert) backup device without patient injury or harm within a 5 minute surgical extension.Further patient impact would not be anticipated.No further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GII DISHED INS SZ 3-4 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10892246
• Report Number: 1020279-2020-06680
• Device Sequence Number: 19654485
• Product Code: JWH
• UDI-Device Identifier: 03596010209320
• UDI-Public: 03596010209320
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2021

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: 71420766
• Device Catalogue Number: 71420766
• Device Lot Number: 20CM10757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 08/02/2021; 09/24/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 08/03/2021; 09/27/2021
• 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; Required Intervention