MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	71425325
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after surgeon evaluation of a tka surgery, it was determined via x ray that one (1) porous tibia baseplate w/jrny lock sz5 lt was loose.It is unknown how the problem was solved.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned devices reveal signs of wear.The inserts returned reveal scratches and gouges.Both the tibial base plate and femoral reveal foreign debris on them.Also there is discoloration on all devices.A lab analysis reveals the components were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.A femur, tibial baseplate, and two insert components were retrieved.The bone contacting surfaces of the femoral component have substance adhered to them.The inserts have a small amount of wear on the articulating and distal surfaces.The tibial baseplate is worn on the proximal surface and locking detail, and still has substance adhered to the distal bone contacting surface.There were no observations of material or manufacturing deviations in the course of this investigation.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.The clinical/medical evaluation concluded that based on the limited information provided, the clinical root cased of the reported loosening of porous tibia bseplate w/jrny lock sz5 lt cannot be definitively concluded.The requested supporting documentation including the operative report, or the surgical technique used in this procedure are not available.The provided radiographs appear to be consistent with the report.The patient impact beyond the reported, tibial baseplate loosening and subsequent revision cannot be determined.The patient¿s current health status is unknown.Therefore, no further 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for knee systems revealed that looseness of components has been identified in possible adverse effects section as a result from trauma, improper implant selection, improper implant positioning, improper fixation, and/or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, size selected, inadequate integration between the cement and bone/implant, 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 future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
B5, d6a, d6b, h6.
Event or Problem Description
It was reported that, after a tka surgery was performed on (b)(6) 2023, it was determined via x ray that one (1) porous tibia bseplate w/jrny lock sz5 lt was loose.A revision surgery was performed on (b)(6) 2023 to solve the problem.Patient health status is unknown.

• Brand Name: POROUS TIBIA BSEPLATE W/JRNY LOCK SZ5 LT
• Common Device Name: 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: 17780517
• Report Number: 1020279-2023-01795
• Device Sequence Number: 5472808
• Product Code: MBH
• UDI-Device Identifier: 00885556733066
• UDI-Public: 885556733066
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71425325
• Device Lot Number: 22AM10185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 12/12/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/09/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female