MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420830
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during left tka, when reducing the gii ps insert sz 5-6 9mm in the gns ii cmt tib size 5 left, the positioner (impactor) tip broke.A smith and nephew back up high flex positioner was used instead, however the gns ii cmt tib size 5 left did not reduce (clicking noise) despite placing the implant correctly.The physician decided to change the tibial baseplate as there were no more inserts available, they re-cut the bone with size 11 polyethylene.Finally, after removing the baseplate and cleaning the remaining cement, a gns ii cmt tib size 6 left was implanted.A delay greater than 30min was reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: d10 (concomitant added), g4 (510k number added).Results of investigation: the insert and the baseplate were returned and evaluated, however, the reported broken inserter was not returned for analysis.The visual inspection revealed the returned genesis ii posterior stabilized insert size 5-6 9mm has damage along the base, more than likely from attempted insertion.A dimensional evaluation performed revealed the insert has signs of damage from attempted use.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.All applicable, critical features that could be measured were within specification.The visual inspection revealed the returned genesis ii non-porous tibial baseplate size 5 left shows signs of normal use.A dimensional evaluation of the baseplate revealed that all applicable critical features for the lock detail were within specification.Based on the evidence provided, the unsatisfactory experience could be confirmed.A review of the production orders 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 insert 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 complaint history for the part number over the past 12 months and for the batch number based on historical data of the baseplate did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that an adequate inventory of implant sizes should be available at the time of surgery.Also, the correct selection of the implant is extremely important; the appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age and activity levels, weight, bone and muscle conditions, etc, this has been identified in the warnings and precautions, and intraoperative section.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.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 for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: d1 (brand name), d2a (product code), d4 (catalog number, lot number, expiration date & unique identifier), h3 (device returned), h6 (medical device problem code, type of investigation, investigation findings).

• Brand Name: GII PS INSERT SZ 5-6 9MM
• 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: 15108705
• Report Number: 1020279-2022-03485
• Device Sequence Number: 17181237
• Product Code: JWH
• UDI-Device Identifier: 03596010209641
• UDI-Public: 03596010209641
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420830
• Device Catalogue Number: 71420830
• Device Lot Number: H2147518
• 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: 07/08/2022
• Supplement Date Received by Manufacturer: 08/23/2022; 03/23/2023
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 09/08/2022; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71420168 / LOT: H2000238
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male