MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 8MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-308

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

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

Trouble seating a sigma partial insert.No patient harms or surgical delays reported.

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.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: SIGMA HP UNI INS SZ3 8MM LM/RL
• 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: 11259333
• MDR Text Key: 229659126
• Report Number: 1818910-2021-02175
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002543
• UDI-Public: 10603295002543
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-53-308
• Device Catalogue Number: 102453308
• Device Lot Number: J2584C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI INS SZ3 8MM LM/RL; SIGMA HP UNI INS SZ3 8MM LM/RL