MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR DEEP FLEX ISRT S1-2 13M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421533
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tkr surgery, the gii cr deep flex isrt s1-2 13m couldn't lock tightly.The procedure was resumed, after a significant delay, with a s+n back-up device.The patient required additional anesthesia.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals scratches and gouges in the surface of the device.The dimensional evaluation revealed that the device has damage that appears to be from attempted use and has the potential to cause an event during attempted mating to the tibial base as described in the complaint.The damage/deformation of several features would not allow for accurate measurement.All measurable critical features that could be measured were within specification.The dimensional inspection of the returned device did not indicate the product was defective at the time of shipment from the manufacturing site.This device is subjected to multiple visual and dimensional inspection during processing, and this type of damage has a high likelihood of detection during these inspections.Based on the evidence provided, the unsatisfactory experience could be confirmed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.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.Factors that could contribute to the reported event include size selected or 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 CR DEEP FLEX ISRT S1-2 13M
• 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: 18164676
• Report Number: 1020279-2023-02258
• Device Sequence Number: 6466464
• Product Code: JWH
• UDI-Device Identifier: 03596010520364
• UDI-Public: 03596010520364
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 71421533
• Device Lot Number: 19HM00230
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female