MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NON-MOD CEM C/R FEM SZ6 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 71420074

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Inadequate Osseointegration (2646); Unspecified Musculoskeletal problem (4535)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, after a left tka was performed on (b)(6) 2007, the patient experienced prosthetic mobilization and degrading arthrosis.This adverse event was solved by a revision surgery performed on (b)(6) 2022, in which the gii non-mod cem c/r fem sz6 lt was explanted.The current health status of the patient is unknown.

Manufacturer Narrative

Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, approximately 15 years after a left tka was performed the patient experienced prosthetic mobilization, degrading arthrosis and a subsequent revision.The patient¿s current health status is unknown.No additional requested information was provided.Without the requested information, the root cause of the reported events cannot be definitively concluded and the patient impact beyond the reported prosthetic mobilization, degrading arthrosis, and revision cannot be determined.It is believed that the native patella was not resurfaced in the primary tka, but this cannot be confirmed.The patient¿s current health status remains unknown.Therefore, no further clinical medical assessment can be rendered.A review of the manufacturing records 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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveal in the possible adverse effects to be aware of migration of components as this may lead to further complications.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 product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient condition 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.

• Brand Name: GII NON-MOD CEM C/R FEM SZ6 LT
• 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: 13590159
• MDR Text Key: 286041771
• Report Number: 1020279-2022-00842
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010205810
• UDI-Public: 3596010205810
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2017
• Device Catalogue Number: 71420074
• Device Lot Number: 07MM07309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2007
• 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; Hospitalization
• Patient Age: 84 YR