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

Catalog Number	102452400
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8775549
• Report Number: 1818910-2019-97907
• Device Sequence Number: 16779241
• Product Code: HRY
• UDI-Device Identifier: 10603295002406
• UDI-Public: 10603295002406
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 102452400
• Device Lot Number: HW7438
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1