MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI A/P SZ3 8MM RMLL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-12-308

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); No Code Available (3191)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).

Event Description

Patient received a right revision of the unicompartmental knee due to pain secondary to loosening.Upon entering the joint, the femoral component was grossly loose at an unknown interface and easily removed.There was no reported product problem of the explanted tibial tray or insert.There was no indication of infection or inflammation in the knee.The patient was revised with competitor products.The patient had the postoperative complications of acute kidney injury, hypotension, and acute anemia secondary to anesthetic medication imbalance and dehydration.The patient was treated with supplemental oxygen, medication adjustment, and aggressive oral and iv fluid intake.The patient did not require a prolonged hospital stay.On (b)(6) 2018, the patient reported healing nicely with no further complications.The revision procedure is captured on (b)(4).Doi: (b)(6) 2012 (bilateral), dor: (b)(6) 2018 (right), doe: 20 nov 2018 (right postoperative aki and anemia), dor: (b)(6) 2019 (left).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: SIGMA HP UNI A/P SZ3 8MM RMLL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10213478
• MDR Text Key: 198186732
• Report Number: 1818910-2020-14709
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002154
• UDI-Public: 10603295002154
• Combination Product (y/n): N
• PMA/PMN Number: K061648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 1024-12-308
• Device Catalogue Number: 102412308
• Device Lot Number: 174126
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ3 RM/LL; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 90