MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. RT-PLUS TIBIAL INSERT 10/14MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 75005493

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported that during revision the inlay was broken.No delay, injury or back up reported.

Manufacturer Narrative

Results of investigation: it was reported that during a revision surgery the pe insert was observed to be fractured.One pe insert, one rt-plus femoral component and one rt-plus tibial base plate were returned for investigation.The reported fracture was confirmed.Visual inspection revealed striations indicating a fatigue fracture with a propagation of the fatigue crack from posterior to anterior direction.Damages to the pe protection and underlying metal as well as a dent on the rotating hinge indicate a potential chronic hyperextension of the knee joint.A review of the production documentation of the tibial insert did not detect any deviation from the standard manufacturing processes.No other complaints have been recorded for this batch of tibial inserts.Operative records indicate that this patient was revised on three previous occasions.The primary implantation of the left tka occurred in 2012.The first revision occurred about 1 year 3 months later, in which a complete synovectomy and exchange of the left knee pe insert was performed.Approximately 8 months after the first revision, a second revision was performed to change the left tka implant to a rotating hinged knee implant, and complete synovectomy and patellar realignment.The third left tka revision occurred about 4.5 years post second revision due to dislocation and massive patellar lateralization.A synovectomy and insert exchange was performed.The most recent, fourth revision was performed 3 months later due to re-dislocation of the left knee, in which a hinged knee was implanted.A radiology report (pre 4th revision) indicated a dislocated left tka with no loosening of the cemented stems.Also noted was demineralization on the lateral femoral condyle periprosthetic fracture, multiple periarticular calcifications emphasized dorsally; pronounced retro-patellar arthritic changes with significant soft tissue swelling with knee joint effusion; vascular sclerosis.The provided x-rays confirm the dislocated implant.Based on the provided records, there is no indication of an additional smith and nephew device involved in previous revision surgeries.Despite the investigation performed no root cause for the reported issue could be determined.There is however to the best of our knowledge no indication that the reported device failed to match specification at the time of manufacturing.No further actions have been initiated.Should further information become available in the future this investigation will be reopened.

Event Description

It was reported that during revision the inlay was found broken.

• Brand Name: RT-PLUS TIBIAL INSERT 10/14MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar TN 06340 ; SZ 06340
• MDR Report Key: 7974355
• MDR Text Key: 123990265
• Report Number: 1020279-2018-02204
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K021714
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: 75005493
• Device Lot Number: D1314155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 09/26/2018
• Patient Sequence Number: 1
• Treatment: 75005515,RT-PLUS MODULAR STEM,G1408333; 75005558,RT-PLUS MOD FEMORAL COMP, UNKNOWN; 75005563,RT-PLUS MOD TIBIAL COMP,H1313169
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 135