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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); No Code Available (3191)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).
Event or Problem 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).
Additional 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
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10213478
• Report Number: 1818910-2020-14709
• Device Sequence Number: 14054734
• Product Code: HRY
• UDI-Device Identifier: 10603295002154
• UDI-Public: 10603295002154
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K061648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIGMA HP UNI FEMORAL SZ3 RM/LL; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 90