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  Injury  

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

Insert to seat, opened alternative inserts all failed to seat.Revised implants to a total.

Manufacturer Narrative

Product complaint # (b)(4).This is a duplicate report of 1818910-2019-94670.1818910-2019-94669 is being retracted as it is 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
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6107428552
• MDR Report Key: 8649397
• MDR Text Key: 146347359
• Report Number: 1818910-2019-94669
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002406
• UDI-Public: 10603295002406
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention