MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG RT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM); PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,

Catalog Number 71420574

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, revision surgery was performed one year after primary procedure due to ptg infection.The information about which device(s) caused the infection was not initially provided.

Manufacturer Narrative

Additional information in h6: additional medical device problem code.Internal reference complaint number: (b)(4).

Manufacturer Narrative

Results of investigation: it was reported that a revision surgery was performed one year after primary procedure due to ptg infection.The revised device(s) used in treatment, were not returned for investigation.A product evaluation could therefore not be conducted and it is unknown which devices were revised.Nevertheless, the batch number of the femoral component device was communicated.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.A complaint history review was performed and no additional complaint for the batch in question (i1822120) was detected.According to ¿lit.No.12.24_ed.07-10¿, infection is stated as a possible side effect.Furthermore, the failure mode and the severity are covered in the rt plus/rt plus modular dfmea.A medical investigation could not be performed as relevant clinical information has not been provided.Based on the conducted investigation, the reported failure mode cannot be confirmed and the root cause for the reported infection issue could not be determined conclusively.There are no indications that the device did not meet the specifications at the time of manufacturing.Should the part be returned or more information become available, the investigation will be reopened.No actions are deemed necessary at this time.Smith+nephew will continue to monitor for similar issues.

• Brand Name: RT PLUS MOD. FEM. COMP RT SZ 8 (CUSTOM)
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• MDR Report Key: 11099933
• MDR Text Key: 224521742
• Report Number: 9613369-2020-00278
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K023667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2021

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: Lay User/Patient
• Device Catalogue Number: 71420574
• Device Lot Number: I1822120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/15/2021; 01/26/2021
• Supplement Dates FDA Received: 01/19/2021; 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71420574/GNS II RESURF PAT 29MM/19AM19414; GNS II RESURF PAT 29MM, LOT 19AM19414; RT-PLUS MOD STEM 16/120 NON-CEM, LOT: UNKNOWN; RT-PLUS MOD TIBIAL COMPONENT 8 CEM, LOT H1902519; RT-PLUS TIBIAL INSERT 8/8MM LOT: D1714383; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; 71420574/GNS II RESURF PAT 29MM/19AM19414; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV; UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR