MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 7-8 13MM; PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Model Number	71420848
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed after 10 years because of a broken post.
Additional Manufacturer Narrative
The associated genesis ii ps insert was returned and evaluated.A lab analysis conducted during this investigation indicated that returned insert and insert post fragment were examined visually and using optical microscopy.No destructive testing was conducted.The insert showed some abrasion, discoloration and deformation in the bearing regions on the superior surface.Minor scratches were observed on the inferior surface of the insert, and material damage could be seen around the periphery of the articulating surface.The device fractured near the base of the post.Significant material deformation was present on the insert around the fracture surface.This fracture could have been caused due to repeated posterior impingement of the femoral cam on the post combined with excessive loads.However, based on the results of this investigation, this could not be isolated as the root cause for this particular failure mode.On the basis of this investigation, no material or manufacturing deviations were found.No relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated genesis ii ps insert was not returned for evaluation.A clinical analysis noted that without the requested clinical information, pathology reports, and the explant a definitive root cause of the implant deformation cannot be determined. however, the length of time in-situ, the age of the patient and history of cancer cannot be ruled as a contributing factors. the impact to the patient beyond the revision cannot be determined. no further clinical/medical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number. without the return of the actual product involved, our investigation of this report is inconclusive.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.Should additional information be received, the complaint will be reopened.

• Brand Name: GII PS INSERT SZ 7-8 13MM
• Common Device Name: PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7644681
• Report Number: 1020279-2018-01217
• Device Sequence Number: 19119159
• Product Code: JWH
• UDI-Device Identifier: 03596010209733
• UDI-Public: 03596010209733
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2019

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 Expiration Date: 02/25/2018
• Device Model Number: 71420848
• Device Catalogue Number: 71420848
• Device Lot Number: 08BT16828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/13/2023; 07/13/2023; 07/13/2023
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/13/2023; 10/06/2018; 07/11/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• 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 Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG