MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REVISION CEM TIB TRAY SZ 2; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number 129435120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); No Code Available (3191)

Event Date 08/26/2011

Event Type  Injury  

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.Concomitant med products: mbt revision cem tib tray sz 2; srom nrh fem w/pin xsmrt 66x58; lps univ tib hin ins xsm 12mm; unknown knee patella component; depuy cmw 2 20g; universal fem slv ful por 31mm; universal stem 75x14mm fluted; srom nrh dist aug xs/s/md 5mm; srom nrh dist aug xs/s/md 10mm; universal stem 75x10mm fluted; mbt tray sleeve por m/l 29mm.

Event Description

(b)(6).Dots.Clinical adverse event received for above the knee amputation related to wound dehiscence.Event is serious and is considered severe.Event is possibly related to device and definitely related to procedure.Doe: (b)(6) 2011; doi: (b)(6) 2011; date of amputation: (b)(6) 2011; (right, knee).

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incident(s) against the provided product/lot combination(s) since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REVISION CEM TIB TRAY SZ 2
• Type of Device: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7781147
• MDR Text Key: 117129058
• Report Number: 1818910-2018-66585
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295025948
• UDI-Public: 10603295025948
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 129435120
• Device Lot Number: E4AAL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2010
• 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 Weight: 78