MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421508
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during procedure, the poly of (1) gii ps hi flex isrt sz 3-4 9 broke inside the patient.It is unknown how the procedure was finished or if there was any delay.Patient´s current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
B5: describe event or problem, d4: lot# and expiration date, d10: device available for evaluation?, h4: device manufacture date and d7: if explanted, give date.Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that the device was found to be fractured along the post.The fractured post was returned along with the rest of the device.A lab analysis performed on the device revealed that the retrieved articular insert and fractured post were examined using visual and macroscopic/microscopic methods.Visual examination showed yellowish discoloration to the insert and damage to the backside of the insert.Yellowish discoloration of the polyethylene of implants can occur when exposed to fluids in or around a joint.Macroscopic/microscopic examination showed burnishing wear on the articular surface of the insert, damage to the post region surface of the insert, and fracture of the post.The post was fractured approximately at the inferior-superior base to mid-point.No damage was observed on the anterior side of the fractured post.No additional unexpected visual features noted.No evidence of deviation in processing or material was found for the retrieved item.No definitive conclusions as to the cause of these issues can be determined.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the reported event.Per case details, the poly insert reportedly, ¿broke¿.No information regarding the specific details surrounding the implant breakage was provided.The patient impact beyond the reported insert "broke¿, and revision cannot be determined.The patient¿s current health status also remains unknown.Therefore, no further clinical medical assessment can be rendered.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.A review of the risk management file 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 product and event.According with the inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of ultra-high-molecular-weight polyethlylene rod and plate shall be controlled.A review made by the quality engineering team revealed that the root cause could not be determined.There were no observations of material or manufacturing deviations in the course of the investigation.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, excessive forces and/or traumatic injury.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 for future complaints and investigate as necessary.We consider this investigation closed.H6: health effect - clinical code and health effect - impact code.
Event or Problem Description
It was reported that, after a tka surgery had been performed with a genesis ii system on an unspecified date, the gii ps hi flex isrt sz 3-4 9 broke.A revision surgery was performed on (b)(6) 2022 to revise the broken insert.Patient's current health status is unknown.

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 9
• 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: 16067132
• Report Number: 1020279-2022-05125
• Device Sequence Number: 6705678
• Product Code: JWH
• UDI-Device Identifier: 03596010492357
• UDI-Public: 03596010492357
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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 Expiration Date: 03/08/2019
• Device Model Number: 71421508
• Device Catalogue Number: 71421508
• Device Lot Number: 09CM07162
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2009
• 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