MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INSERT STD 1.5 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number TRULIANT TIB IMP CR INSERT STD 1.5 10MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fluid Discharge (2686); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2022

Event Type  Injury  

Event Description

It was reported that a 63 yo female patient, initial left knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2022, approximately 2 years 10 months post the initial procedure to swap the recall implant.The patient was last known to be in stable condition following the event.The device is not returning as the hospital refused to return.

Manufacturer Narrative

No device return anticipated due to the hospital refused to return them.Concomitants medical devices: 02-020-13-0215 - truliant cr cem fem cr cem left sz 1.5 5523615, 02-022-45-1515 - truliant tib fit tray cem sz 1.5f / 1.5t 5854393, 200-02-29 - three peg patella 29mm 5893247.(b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent poly swap/revision has been reported to be due to the device recall; no other reason reported.

Event Description

The poly was swapped due to the recall.No other reason reported.There were no reported issues during the revision surgical procedure.No additional information.

Manufacturer Narrative

After review of additional information received the following sections, b5, g4, and h6-health effect - clinical code have been updated accordingly.

Event Description

B5: from the operative report: the patient is a 63 yo female with history of left total knee arthroplasty approximately 3-4 years ago, which has started to develop an effusion in the last year or so, with polyethylene recall, she did present to outpatient orthopedic clinic with complaints of left knee effusion, which was present on exam as well as creating some feelings of pain and tightness to the knee.This is something that has been progressive that initially was not present.Esr and crp was negative to rule out infection, and ct scan ensured no osteolysis or evidence of loosening of the metallic impants.Once this was established and associated with polyethelene recall and effusion, otherwise without an explanation, did elect for a polyethylene exchange.All the risks and benefits were dictated to her, and she is willing to accept these risks and benefits.The consents are signed on the chart with all her questions answered to her satisfaction.Procedure in detail: opeerative consents were reviewed, site was marked.The patien was escorted back to the operative suite.She underwent spinal sedation.The left lower extremity was prepped and draped in sterile fashion.A nonsterile tourniquet was placed prior to prepping and draping and it was elevated to 300 mmhg after the limb was levated 3-5 minutes.An anterior incision was created in medial parapatellar arthrotomy.She did have a large effusion, which was nonpurulent and no metallosis present.I then performed a synovectomy of the suprapetellar pouch and medial and lateral gutters of the knee.We were able to isolate the polyethylene, able to remove it from the tibial tray, and taken to the back table for preservation.At this point, there was no othe pathology noted in the knee.There was no evidence of any impingement or any kind of degadation of the metallic implants and they were deemed competent.The polyethylene on the patella looked to be pristine as well.At this point, we then performed a 3-5 minute betadine soak and pericapsular cocktail injection and we placed a new polyethylene of the same thickness and this was easily tamped down into position after we had solid fixation of the polyethylene.We then performed another 3-5 minute betadine soak, deflated our touniquet and then removed the packing.We copioulsy irrigated the wound again with antibiotic-impregnated saline, placed 1 gram of powder vacomycin intra-articularly, and reapproximated medial prapatellar arthrotomy with #1 vicryl and #1 stratafix suture.Subcutaneous tissue was reapproximated with 2-0 vicryl, 3-0 vicryl, steri-strips, 4x4's, and bulky jones dressing.She was awoken and transferred to the recovery room in stable condition.No complications occurred during the case.Postoperative course: she remained in the hospital for perioperative antibiotics, dvt prophylaxis, mobilization and pain control.They followed her hospital course and began mobilzation to tolerance.

Event Description

Legal case.The plaintiff has suffered and continues to suffer permanent and debilitating injuries and damages, including but not limited to pain, swelling, effusion, knee popping, knee giving away, difficulty walking, antalgic gate, and other injuries presently undiagnosed, which all require ongoing medical care.No further information.

Manufacturer Narrative

B3: corrected event date from 8/1/2022 to 8/17/2022.D6b: corrected explant date from (b)(6) 2022 to (b)(6) 2022.

Manufacturer Narrative

H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issue.The cause of the subsequent revision was most likely related to pain as reported.There were no noted problems with the implants found during the surgical revision procedure.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT TIB IMP CR INSERT STD 1.5 10MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15569707
• MDR Text Key: 301512188
• Report Number: 1038671-2022-01278
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862306159
• UDI-Public: 10885862306159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRULIANT TIB IMP CR INSERT STD 1.5 10MM
• Device Catalogue Number: 02-022-47-1510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female