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

Model Number	1024-52-400
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
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
While operating original insert did not lock, surgeon tried many times then we take out and insert the another one which got locked in very first go.
Additional 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 reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Corrective action was not indicated.

• 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: 9900636
• Report Number: 1818910-2020-09636
• Device Sequence Number: 2827948
• Product Code: HRY
• UDI-Device Identifier: 10603295002406
• UDI-Public: 10603295002406
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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 Model Number: 1024-52-400
• Device Catalogue Number: 102452400
• Device Lot Number: HG0366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1