MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL SZ2 LM/RL; EARLY INTERVENTION : KNEE FEMORAL

Model Number 1024-07-200

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 10/13/2020

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.

Event Description

The patient was revised to address loosening of the femoral component at the cement to implant interface.Depuy cement was used.It was also reported that they revised to a total knee.Tibia was well fixed.No additional information.Doi: (b)(6) 2019.Dor: (b)(6) 2020; left 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 at this time.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI FEMORAL SZ2 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: 10754729
• MDR Text Key: 213642200
• Report Number: 1818910-2020-23524
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295001720
• UDI-Public: 10603295001720
• 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,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-07-200
• Device Catalogue Number: 102407200
• Device Lot Number: HH4615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ2 LM/RL.; SIGMA HP UNI INS SZ2 7MM LM/RL.; SIGMA HP UNI INS SZ2 7MM LM/RL.; SIGMA HP UNI TIB TRAY SZ2 LMRL.; SIGMA HP UNI TIB TRAY SZ2 LMRL.; SMARTSET HV BONE CEMENT 40G.; UNK CEMENT SMARTSET.; SIGMA HP UNI FEMORAL SZ2 LM/RL; SIGMA HP UNI INS SZ2 7MM LM/RL; SIGMA HP UNI TIB TRAY SZ2 LMRL; UNK CEMENT SMARTSET
• Patient Outcome(s): Required Intervention