MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420818
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery.The surgeon first performed a test with femur ps 5 left and gii ps insert sz 3-4 11mm.Then, the surgeon proceeds to place the gii ps insert sz 3-4 11mm and slides it from interior to posterior and finally uses the insert reducer to finish fixing it, but the insert did not engaged and click so it remained raised 1mm.The surgeon repeated the maneuver three times, ensuring that there was nothing that prevents the proper assembly of the insert with the tibial base, but the insert was always raised by 1mm and did not made the click that ensured a correct assembly.The procedure was successfully completed with a delay less than or equal to 30 minutes using a smith and nephew back up device.The patient was not harmed.
Additional Manufacturer Narrative
H3, h6: 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.At this time, we have no 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 a 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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The returned device has damage among the base, more than likely from attempted insertion.A dimensional inspection was attempted, but the device was too damaged from the attempted insertion to obtain accurate measurements.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could not be corroborated.Some potential probable causes for this event could include a 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 is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 3-4 11MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11803263
• Report Number: 1020279-2021-03970
• Device Sequence Number: 3909642
• Product Code: JWH
• UDI-Device Identifier: 03596010209580
• UDI-Public: 03596010209580
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420818
• Device Catalogue Number: 71420818
• Device Lot Number: J2011191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 04/06/2022
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 09/20/2021; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 80 KG