MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ4 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-07-400

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

Patient Problem Pain (1994)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was revised to address pain.Depuy cement was used.No surgical delay.Doi: (b)(6) 2013, dor: (b)(6) 2021, left knee.

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 01-jan-2015.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI FEMORAL SZ4 LM/RL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11444305
• MDR Text Key: 238606201
• Report Number: 1818910-2021-04689
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295001744
• UDI-Public: 10603295001744
• Combination Product (y/n): N
• PMA/PMN Number: K070849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

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
• Device Operator: Health Professional
• Device Model Number: 1024-07-400
• Device Catalogue Number: 102407400
• Device Lot Number: 265351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ4 LM/RL; SIGMA HP UNI INS SZ5 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ5 LMRL; SMARTSET GMV 40G US EO; SIGMA HP UNI FEMORAL SZ4 LM/RL; SIGMA HP UNI INS SZ5 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ5 LMRL; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 107