MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 3-4 RT10; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number 74023232

Device Problem Positioning Problem (3009)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient had a manipulation under anesthesia since two previous dislocations occurred in the past.The decision was made to open the joint and investigate further as no dislocation was possible during the mua.Upon opening the joint the surgeon determined that under extreme effort dislocation was theoretically possible.The journ art ins bcs std 3-4 rt10 was replaced, the other implants were firm.The surgeon decided after trialing, to install a thicker revision poly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms minor damage to the locking detail due to the removing the explant.The visual also confirms wear of the condyle on the insert and the there is discoloration on the insert.A medical investigation was conducted and confirms per complaint details, a patient had a manipulation under anesthesia due to two prior dislocations and during the procedure, the surgeon decided to perform an open exploratory to investigate further, as no dislocation was possible during the mua.Reportedly, upon opening the joint the surgeon determined that ¿under extreme effort dislocation was theoretically possible¿; therefore, the insert was replaced/upsized with a thicker revision poly.Per correspondence, no patient medical history is available.Without the requested medical documentation, the clinical root cause and patient impact beyond the reported dislocations and subsequent mua followed with revision could not be concluded.No further medical assessment is warranted at this time.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.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 risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 3-4 RT10
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11371590
• MDR Text Key: 233242359
• Report Number: 1020279-2021-01554
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010555007
• UDI-Public: 03596010555007
• Combination Product (y/n): N
• PMA/PMN Number: K042515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 74023232
• Device Catalogue Number: 74023232
• Device Lot Number: 09AM24894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 06/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention