MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL ADAPTOR BOLT; UNK KNEE FEMORAL ADAPTOR BOLT

Catalog Number UNK KNEE FEMORAL ADAPTOR BOLT

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Not Applicable (3189); No Code Available (3191)

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

This complaint is to capture the multiple cases with the same problem reported in (b)(4).Tc3 bolt and adaptor broke in patient.Outcome was a revison for tc3 femoral component.I don¿t have any implant product lots or part numbers but see descriptions below: femur: 5 tc3.Distal augments: 16 medial and lateral.+2 bolt & 5 degree adaptor.Sz 5 ps rp poly which was removed by osteotome poly from poly bullet.There was metal debris in the joint and the sleeve was well fixed.Xrays and implant will be uploaded.Surgeon dr.(b)(6) removed the femoral component after 30 minutes of work.The 5 degree adaptor was still engaged in the sleeve which we were able to break the taper with slap hammer and five grip using the bolt.There have been multiple cases with the same problem which i have not been a part of.Surgeon was able to re-engage morse taper with an srom hinge implant.Patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> revison, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, if yes, describe --> xrays will be attached , is the patient part of a clinical study --> unknown, (b)(4).Device property of -->none, device in possession of -->none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL ADAPTOR BOLT
• Type of Device: UNK KNEE FEMORAL ADAPTOR BOLT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9874441
• MDR Text Key: 189845427
• Report Number: 1818910-2020-09132
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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: UNK KNEE FEMORAL ADAPTOR BOLT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN KNEE FEMORAL ADAPTOR; UNKNOWN KNEE FEMORAL ADAPTOR BOLT
• Patient Outcome(s): Required Intervention