MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 11MM LMRL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-511

Device Problems Difficult to Insert (1316); Device Damaged Prior to Use (2284)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 09/25/2020

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

It was reported that sigma hp poly would not engage in the tibial tray.Seems to have a deformed lip on the insert there was a surgical delay of 10 minutes.

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 INS SZ5 11MM LMRL
• 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: 10672145
• MDR Text Key: 211110442
• Report Number: 1818910-2020-22200
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002673
• UDI-Public: 10603295002673
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-53-511
• Device Catalogue Number: 102453511
• Device Lot Number: H50281
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK KNEE TIBIAL TRAY UNI; UNK KNEE TIBIAL TRAY UNI
• Patient Age: 64 YR