MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ4 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Catalog Number 102452400

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 05/03/2019

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

Tibial insert fixed bearing unicondylar.Serial number ¿ (b)(4).Lot number ¿ j16x18.Date of manufacture ¿ 2018.12.11.Date of expiry ¿ 2023.11.30.Serial number ¿ (b)(4).Lot number ¿ hj0460.Date of manufacture ¿ 2017.10.23.Date of expiry ¿ 2022.09.30.Serial number ¿ (b)(4).Lot number ¿ hj4036.Date of manufacture ¿ 2017.10.30.Date of expiry ¿ 2022.09.30.Tibial tray unicondylar metal backed.Serial number ¿ (b)(4).Lot number ¿ hw7438.Date of manufacture ¿ 2018.05.16.Date of expiry ¿ 2028.04.30.(b)(6) - prolonged procedure and procedure change from partial knee replacement to a total knee replacement.

Manufacturer Narrative

Product complaint #: (b)(4).This is a duplicate report of 1818910-2019-94670.1818910-2019-97907 is being retracted as it is a report duplication.1818910-2019-94670 will be kept for investigation purposes.

• Brand Name: SIGMA HP UNI TIB TRAY SZ4 RMLL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8775549
• MDR Text Key: 169948476
• Report Number: 1818910-2019-97907
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002406
• UDI-Public: 10603295002406
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102452400
• Device Lot Number: HW7438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1