MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ4 8MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number 102454408

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 05/03/2019

Event Type  malfunction  

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

Tibial insert fixed bearing unicondylar: serial number ¿ (b)(4), lot number ¿ j16x18, date of manufacture ¿ 12/11/2018, date of expiry ¿ 11/30/2023.Serial number ¿ (b)(4), lot number ¿ hj0460, date of manufacture ¿ 10/23/2017, date of expiry ¿ 09/30/2022.Serial number ¿ (b)(4), lot number ¿ hj4036, date of manufacture ¿ 10/30/2017, date of expiry ¿ 09/30/2022.Tibial tray unicondylar metal backed: serial number ¿ (b)(4), lot number ¿ hw7438, date of manufacture ¿ 05/16/2018, date of expiry ¿ 04/30/2028.(b)(6) centre - prolonged procedure and procedure change from partial knww replacement to a total knee replacement.

Manufacturer Narrative

Product complaint #
=
> (b)(4).This is a duplicate report of 1818910-2019-94672.1818910-2019-97906 is being retracted as it is a report duplication.1818910-2019-94672 will be kept for investigation purposes.

• Brand Name: SIGMA HP UNI INS SZ4 8MM RM/LL
• 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: 8775548
• MDR Text Key: 150552578
• Report Number: 1818910-2019-97906
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002895
• UDI-Public: 10603295002895
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 102454408
• Device Lot Number: HJ4036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1