MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 3 LEFT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420164
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, three gii dished ins sz 3-4 9mm and one gii c/r art ins sz 3-4 9mm could not be inserted far enough into the dovetail guide and be finally fixed in the already implanted gns ii cmt tib size 3 left (lot no.H2136412).A fifth attempt was made with a lgn xlpe dished isrt sz 3-4 9mm, which could be fixed in the tibia by using an additional hammer blows and force.A significant delay occurred as a consequence of these issues.No other complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Section h10: this complaint reports five attempts performed by a surgeon to position five different inserts.The positioning was successful after the fifth attempt.Four inserts were returned for evaluation.Considering that the base plate is implanted into the patient¿s anatomy, and a visual inspection of the returned mating inserts confirmed to be damaged from the attempted insertions, it was not possible to evaluate the interaction between the returned product and the implanted base plate.Nevertheless, based on the testimonial evidence, the contribution of the product to the event was corroborated.Even though over the previous 12 months, similar events were identified for the reported inserts, no similar events were identified for the specific batches.And a review of complaint history over the past 12 months for the reported tibial baseplate part number and the specific batch number did not reveal any similar events.In addition, a review of the manufacturing records for all devices involved, inserts and tibial base plate, 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 files revealed that 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 these devices and failure mode.Possible causes could include but are not limited to insertion technique or procedural variance.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.Internal complaint reference number: (b)(4).

• Brand Name: GNS II CMT TIB SIZE 3 LEFT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 13664303
• Report Number: 1020279-2022-01013
• Device Sequence Number: 4659206
• Product Code: JWH
• UDI-Device Identifier: 03596010206251
• UDI-Public: 03596010206251
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 71420164
• Device Catalogue Number: 71420164
• Device Lot Number: H2136412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown