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

Model Number 1024-08-400

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

Patient Problem Pain (1994)

Event Date 03/31/2021

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

Patient was revised due to pain.Total knee revision was done.Doi: (b)(6) 2015 dor: (b)(6) 2021 right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI FEMORAL SZ4 RM/LL
• Type of Device: EARLY INTERVENTION : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11676125
• MDR Text Key: 245759915
• Report Number: 1818910-2021-08078
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295001805
• UDI-Public: 10603295001805
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-08-400
• Device Catalogue Number: 102408400
• Device Lot Number: 639242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ4 RM/LL; SIGMA HP UNI INS SZ4 7MM RM/LL; SIGMA HP UNI TIB TRAY SZ4 RMLL; SMARTSET HV BONE CEMENT 40G; SIGMA HP UNI FEMORAL SZ4 RM/LL; SIGMA HP UNI INS SZ4 7MM RM/LL; SIGMA HP UNI TIB TRAY SZ4 RMLL; SMARTSET HV BONE CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR