MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 71425327

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case(b)(4).

Event Description

It was reported that, after tka surgery had been performed on (b)(6) 2021, the patient experienced a loosening of the porous tibia bseplate w/jrny lock sz7 lt.This incident was determined via x-rays.A revision surgery has been scheduled but the date still unknown.Currently patient complains of persistent pain in knee.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the surgeon provided analysis of the two x-rays does confirm the reported loosening of the tibial baseplate, however, with the limited information provided, the definitive clinical root cause of the reported pain and loosening cannot be determined.According to the report, the patient¿s pain persists, and a revision surgery has been scheduled, however, there is no confirmation that the surgery has been performed.Therefore, the patient impact beyond the reported loosening of the tibial baseplate, the persistent pain, and the scheduled revision cannot be confirmed nor concluded.Should any additional relevant medical documentation be provided, this case would be re-assessed.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 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 abnormal motion over time, bone degeneration, loss of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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.Additional information: d8 corrected data: h1/h2 (type of reportable event).

• Brand Name: POROUS TIBIA BSEPLATE W/JRNY LOCK SZ7 LT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 17813325
• MDR Text Key: 324192535
• Report Number: 1020279-2023-01840
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556733080
• UDI-Public: 885556733080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71425327
• Device Lot Number: 21FM17194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male