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

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2020

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

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.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> 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
• 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: 9900636
• MDR Text Key: 190358222
• Report Number: 1818910-2020-09636
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 1024-52-400
• Device Catalogue Number: 102452400
• Device Lot Number: HG0366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 07/03/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1