MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE TIBIAL STEM; KNEE IMPLANT : TIBIAL STEM

Catalog Number UNK KNEE TIBIAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled, "megaprosthesis in distal femur nonunions in elderly patients¿experience from twenty four cases." written by raja bhaskara rajasekaran, dhanasekara raja palanisami, rajkumar natesan, dheenadhayalan jayaramaraju, and shanmuganathan rajasekaran published by international orthopaedics published online on 7 august 2019 was reviewed.The article's purpose was to evaluate the outcomes and complications following cemented modular distal femoral endoprosthesis used in managing distal femur nonunions (dfn) in elderly patients.Data was compiled procedures that took place between 2012 and 2016 resulting in 24 patients discussed in the article.Out of the 24 patients (listed in table 1 with patient identifiers), 18 patients had depuy products implanted during the procedure.A total of 7 patients experienced a type of complication, 5 of the 7 had depuy implants (refer to table 2 and cross reference narrative descriptions for further details).Specifically 2 of the 7 patients experienced bone cement implantation syndrome (bcis) that were implanted with depuy products but the cement manufacturer is not identified.Patellar resurfacing not performed.Figure 1 provides illustrative examples lps prosthesis utilized in a (b)(6) patient with no associated adverse events in caption description; figures 2 and 3 are identified as radiographic depictions of non-depuy products.Depuy products: lps distal femoral system (femoral stem, femoral segment, femoral component, insert, hinge pin, tibial tray, tibial sleeve, tibial stem).Adverse events: patient c (b)(6) female experienced bcis with symptoms of decreased oxygen level and decreased blood pressure treated with increased oxygen supplementation, aggressive resuscitation with intravenous fluid combined with vasopressor supplementation.Cement manufacturer unknown.Recovered out of icu and noninvasive ventilation 2 days post-op without further complications.Patient e (b)(6) female (pmh of obesity and diabetes) developed 3 cm decubitus ulcer treated "wound care", topical powder and air mattress.Ulcer healed subsequently.No further complications and death occurred 2 years post-op attributed to renal failure.Patient h (b)(6) male presented with pain and swelling in right calf 6 weeks post-op diagnosed with non-occlusive thrombus in right posterior tibial and peroneal veins.He was treated with subcutaneous enoxaparin sodium injections for 6 weeks with subsequent resolution.Patient k (b)(6) male (pmh of diabetes, hypertension and ejection fraction of 50%) became hypotensive evening of surgery managed with volume replacement.On second post-operative day he exhibited fatigue and disorientation and treated with iv therapy as sodium level was 122 meq/l.Remained in high dependency unit managed with iv for 6 delays and then returned to ward with no further complications.Patient x (b)(6).Male (pmh of hypertension and ejection fraction 60%) "developed intraoperative dyspnea and disorientation" with tourniquet released and diagnosed with bcis.He was treated immediately with resuscitation and managed with fluids and vasopressors.He required intubation and post-op ventilation for three days with lung parameters improved and weaned off ventilator.No further complications.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: UNKNOWN KNEE TIBIAL STEM
• Type of Device: KNEE IMPLANT : TIBIAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10167803
• MDR Text Key: 196621291
• Report Number: 1818910-2020-14081
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE TIBIAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention