MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 5 LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71433345
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tka, after performing femoral cuts with the gii mis dcf ap cutting block 5, the gii spc reamthru cr trial-size 5 left did not match the chamfer cuts previously resected.Due to this, the surgeon manually performed again the chamfer cuts, which allowed the size 5 implant to fit well, but still were not aligning with the size 5 femoral trial.Surgery was completed, after a non-significant delay, by placing the initially planned size 5 implant.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
Section h3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.We consider this investigation closed.

• Brand Name: GII SPC REAMTHRU CR TR SZ 5 LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 19344948
• Report Number: 1020279-2024-00967
• Device Sequence Number: 12530129
• Product Code: HRY
• UDI-Device Identifier: 00885556031926
• UDI-Public: 00885556031926
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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 Catalogue Number: 71433345
• Device Lot Number: 09EM20230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GII CTTNG BLK 5: 71441153, 06KM05453
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 75 KG