MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 7-8 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71421522

Device Problem Degraded (1153)

Patient Problems Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2015, the patient underwent a revision surgery on (b)(6) 2023 due to wear of the gii ps hi flex isrt sz 7-8 9.During this surgery the gii ps hi flex isrt sz 7-8 9 was exchanged.The current status of the patient is good.

Manufacturer Narrative

Corrected data: h6 (health effect - impact code).Please note that the coded delay was reported under report number 1020279-2023-01350.

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2015, the patient underwent a revision surgery on (b)(6) 2023 due to wear of the gii ps hi flex isrt sz 7-8 9, which caused severe loosening and instability of the knee.During this surgery the gii ps hi flex isrt sz 7-8 9 was exchanged.The current status of the patient is good.

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 the limited documentation provided, the reported wear, severe loosening and instability led to the revision; however, definitive contributing clinical factors could not be concluded.The patient current health status is reportedly good.Further impact could not be determined.No further medical assessment can be rendered at this time.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 for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents the knee systems reveal in 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.Corrected data: b5, h6 (health effect - clinical code).

• Brand Name: GII PS HI FLEX ISRT SZ 7-8 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: 17164060
• MDR Text Key: 317544507
• Report Number: 1020279-2023-01341
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: 71421522
• Device Catalogue Number: 71421522
• Device Lot Number: 14BM21892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2014
• 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
• Treatment: 71420108/14BM12987/GII NONPOROUS PS FEM SZ 7 LT; 71420172/14BM12549/GNS II CMT TIB SIZE 7 {} LEFT
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 82 KG