MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421524
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr.Internal reference number: (b)(4).
Event or Problem Description
It was reported that during a revision surgery that required a knee joint replacement.The gii ps hi flex isrt sz 7-8 insert could not be implanted.The procedure was resumed, after a significant delay, with an s+n backup device.No injury was reported as a consequence of this issue.
Event or Problem Description
It was reported that, during a knee revision surgery, a genesis ii ps high flexion insert size 7 8 13mm could not be implanted.The procedure was resumed, after a delay greater that 30 min, with an s+n back up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H11 ¿ corrected data.B5- describe event or problem - please note that the mentioned revision surgery was reported under report number 1020279-2023-01341.
Additional Manufacturer Narrative
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 visual also reveals the device has damage along the base, more than likely from attempted insertion.A dimensional evaluation reveals the returned complaint device's anterior lock and posterior dovetail features are damaged based on visual inspection.This damage appears to be from attempted use.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.A dimensional inspection could not confirm the stated failure mode.The dimensional inspection of the returned device did not indicate the product was defective at the time of shipment from the manufacturing site.Instead, the device has signs of damage from attempted use in surgery.A dimensional inspection was attempted; the damage/deformation of several features would not allow for accurate measurement.All measurable critical features that could be measured were within specification.Based on the evidence provided, the unsatisfactory experience could be confirmed.A review of complaint history revealed a 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.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.H10 ¿ additional information.D8 / d9- device returned to manufacturer, date device returned to manufacturer h11 ¿ b5- describe event or problem.G2- report source.
Event or Problem Description
It was reported that, during a knee revision surgery in which unknown devices were explanted, a genesis ii ps high flexion insert size 7-8 13mm could not be implanted.The procedure was resumed, after a delay greater that 30 min, with an s+n back-up device.No injury was reported as a consequence of this issue.

• Brand Name: GII PS HI FLEX ISRT SZ 7-8 13
• 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: 17177210
• Report Number: 1020279-2023-01350
• Device Sequence Number: 15155707
• Product Code: JWH
• UDI-Device Identifier: 03596010492999
• UDI-Public: 03596010492999
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2023

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: 71421524
• Device Catalogue Number: 71421524
• Device Lot Number: 19LM07088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 07/27/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/28/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 82 KG