MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT CEM KEEL TIB TRAY SZ6; KNEE TIBIAL TRAY

Model Number 1294-33-160

Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Distress (2329); Discomfort (2330); Injury (2348); Joint Disorder (2373); No Code Available (3191)

Event Date 08/29/2017

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.

Event Description

Patient initiated form received.It was reported that the patient was revised due to so much pain and suffering.Doi: (b)(6) 2012: dor: (b)(6) 2017 (left knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.

Event Description

Revision for loosening of the femoral and tibial components, pain, and swelling.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.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.

Event Description

Litigation record received.Litigation alleges pain, injury, swelling, stiffness, weakness, discomfort, emotional distress and effusion in the left knee with documented infection.It was also confirmed that the indication for surgery was "the left tkr with aseptic loosening of the femoral and tibial components.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 5-nov-2020: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: MBT CEM KEEL TIB TRAY SZ6
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopedics drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 7141809
• MDR Text Key: 95599741
• Report Number: 1818910-2017-52432
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295025818
• UDI-Public: 10603295025818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: 1294-33-160
• Device Catalogue Number: 129433160
• Device Lot Number: 3477040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• Date Device Manufactured: 07/05/2012
• 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: 59 YR