MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT TRAY SLEEVE POR M/L 61MM; KNEE OTHER IMPLANT

Catalog Number	129454130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Foreign Body Reaction (1868)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
It states that the patient with abnormal gigantism will undergo revision because of fracture of s-rom noiles rotating hinge knee stem.Update nov 14, 2017 additional information received.Customer reported to (b)(6): change of tibial components of knee-tep on (b)(6) 2011.In (b)(6) 2017 a fracture of taper of tibial part of prosthesis was suspected after radiological examination.Revision with change of tibial components on (b)(6) 2017.Intraoperatively a fracture of taper at the connection of tibial plateau to tibial stem was seen.Update: 12/13/2017 medical records reviewed.In addition to what was previously reported, there was loosening of the tibial component of the noiles right-knee joint tep with screw breakage at the transition from sleeve to stem.The patient then had increased instability and falls.Radiographs are reported to show the tibial component disconnected.During this revision, the surgeon noted a discolored synovia in the manner of metallosis and an old hematoma.The medical notes reported that the patient was implanted with a noiles knee prosthesis on (b)(6) 2011 due to an infection of previous implant.Currently, it is not known if those were depuy components.
Additional Manufacturer Narrative
This product was created in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.   if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This medwatch as reported in error, so this medwatch is being rejected.

• Brand Name: MBT TRAY SLEEVE POR M/L 61MM
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7116616
• Report Number: 1818910-2017-29701
• Device Sequence Number: 13678064
• Product Code: NJL
• UDI-Device Identifier: 10603295026440
• UDI-Public: 10603295026440
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 129454130
• Device Lot Number: CS7FD1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017; 04/25/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 12/14/2017; 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 130