MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 7-8 9MM; PROSTHESIS, KNEE, PATELLOFEM, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY

Model Number	71420844
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference number: (b)(4).
Event or Problem Description
It was reported that, after total knee arthroplasty was performed on an unspecified date, the implanted genesis ii posterior stabilized insert size 7-8 9mm broke off.This adverse event was treated by conducting a revision surgery on (b)(6) 2021.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The contribution of the device to the reported event could not be corroborated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured along the post, rendering the device inoperable.The fractured component was returned.A review of complaint history revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that this case reports that a broken ps insert was found during the revision.Two photos of the returned device supports the reported breakage.The date of the primary tka is unknown.Reportedly, ¿surgery to remove and replace poly was successful" and patient was transferred to post-operative recovery.Per correspondence no further information on the patient is available and the patient¿s current health status is unknown.Without the requested clinically relevant information, the root cause of the reported ps insert breakage cannot be definitively concluded.The patient impact beyond the broken ps insert and revision could not be determined.Further patient impact beyond the reported could not be assessed.Therefore, no further medical assessment could be rendered at this time.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 and instructions for use document 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.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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 PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEM, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY
• 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: 12748306
• Report Number: 1020279-2021-07825
• Device Sequence Number: 20012093
• Product Code: JWH
• UDI-Device Identifier: 03596010209719
• UDI-Public: 03596010209719
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71420844
• Device Catalogue Number: 71420844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown