MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number 71453231

Device Problem Device Fell (4014)

Patient Problem Injury (2348)

Event Date 12/20/2018

Event Type  Injury  

Event Description

It was reported that during a revision procedure, insert disengaged in patient.No delay reported.No revision surgery performed.Backup available.No injury or impact to the patient reported yet.

Manufacturer Narrative

The associated legion ps high flexion insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the tibial component was examined via visual and microscopic inspection.Damage was observed on the articular surface, anterior lock, and posterior lock of the tibial insert.Due to the noted damage to the lock detail, the insert could not be dimensionally inspected.No manufacturing deviations were noted during this investigation.Based on the results of this analysis, the exact cause of revision was not able to be determined.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical analysis noted that no supporting documents were provided to confirm the reported issue or to determine the root cause of this reported occurrence.The patient may experience possible pain or brief post-op rehab.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 9MM
• Type of Device: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8245553
• MDR Text Key: 132983278
• Report Number: 1020279-2019-00160
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556034620
• UDI-Public: 00885556034620
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/07/2019

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 Catalogue Number: 71453231
• Device Lot Number: 14ET42079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 04/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention