MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRH TIB PLAT ASSY SM 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number 621613

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision of s-rom-noiles knee prosthesis because of fracture of unidentified metal part.Doi: (b)(6) 2012 alio loco, dor: (b)(6) 2018.

• Brand Name: SROM NRH TIB PLAT ASSY SM 21MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7396698
• MDR Text Key: 104419951
• Report Number: 1818910-2018-56695
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295178989
• UDI-Public: 10603295178989
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2014
• Device Catalogue Number: 621613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Date Device Manufactured: 12/08/2009
• 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
• Patient Age: 68 YR