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

Device Problems Peeled/Delaminated (1454); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that, after a tka surgery done 12 years ago, patient underwent a revision surgery on (b)(6) 2023 due to unclear circumstances.During this revision, a gii ps hi flex isrt sz 3-4 9 was explanted.During the procedure it was noticed that the lateral compartment was open while the medial compartment was tight.No patella.The explanted insert presented medial wear and delamination, with the post also being rounded on the medial side.An external rotation of the tibial component was done along with resurfacing of the patella.The procedure was completed using a smith and nephew back-up device after a significant delay.Current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on a review of the information provided, the definitive clinical root cause of the unspecified adverse event that led to the revision could not be determined.Although, we cannot rule the insert age and the explanted insert findings of medial wear and delamination, with the post also being rounded on the medial side as the likely contributory factors.Subsequently, the intra-operative issue with locking of the insert was resolved with a change in the surgical technique by the surgeon use of a lgn ps high flex xlpe sz 3-4 11mm with a small amount of cement in the front of the tray to lock the replacement insert.It was reported the procedure completed with a back-up; however, the current health status of the patient is unknown.Therefore, the patient impact beyond the reported one-hour surgical delay and insert wear and the modified surgical with a change to a to competitor cement cannot be determined.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in the possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may be initiated by particles of cement, metal, or other debris which can cause abrasion of the articulating surfaces.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.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.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 friction or joint tightness.Based on this investigation, the need for corrective action is not indicated.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.Intra-operative issue with locking of the insert has already been covered under internal reference number (b)(4).

• Brand Name: GII PS HI FLEX ISRT SZ 3-4 9
• Type of Device: 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: 17114099
• MDR Text Key: 317029919
• Report Number: 1020279-2023-01287
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010492357
• UDI-Public: 03596010492357
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 71421508
• Device Catalogue Number: 71421508
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention