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

Catalog Number	102454408
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
(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 ¿ 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This is a duplicate report of 1818910-2019-94671.1818910-2019-97904 is being retracted as it is a report duplication.1818910-2019-94671 will be kept for investigation purposes.

• Brand Name: SIGMA HP UNI INS SZ4 8MM RM/LL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8775547
• Report Number: 1818910-2019-97904
• Device Sequence Number: 14088388
• Product Code: HRY
• UDI-Device Identifier: 10603295002895
• UDI-Public: 10603295002895
• 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 Expiration Date: 11/30/2023
• Device Catalogue Number: 102454408
• Device Lot Number: J16X18
• 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