MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN KNEE FEMORAL ADAPTOR BOLT

Catalog Number UNK KNEE FEMORAL ADAPTOR BOLT

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/25/2018

Event Type  Injury  

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

Der states that the surgeon called and saying that his patient had tc3 implants then realized that it has a nickel allergy.Surgeon tried to revise her knee and convert her to a nickel free option.Surgeon said when removing the femoral sleeve that he fractured her femur and that she would now need a hinge/distal femoral component.At that point he did not have those options available she closed the patient back up leaving the mbt revision sleeve and femoral sleeve with stem attached.Surgeon said that he called an engineer at competitor because he knew they still made custom implants and depuy synthes does not.An engineer at the competitor told him that depuy synthes does have a special program for ¿hardship/one of cases¿ and gave surgeon the name and number of the depuy synthes engineer.After calling the depuy synthes engineer it was confirmed that we can special make nickel free components doe: (b)(6) 2018; right knee.

Manufacturer Narrative

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

• Brand Name: UNKNOWN KNEE FEMORAL ADAPTOR BOLT
• Type of Device: KNEE FEMORAL ADAPTOR BOLT
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7541464
• MDR Text Key: 109165206
• Report Number: 1818910-2018-60448
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL ADAPTOR BOLT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• 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: 60 YR