MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL BODY

Catalog Number UNK SHOULDER HUMERAL BODY

Device Problem Separation Problem (4043)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination, however review of the received mating device finds evidence of implant disassociation.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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.

Event Description

It was reported that the reported device was used during the prosthetic arthroplasty of shoulder joint on (b)(6) 2017 due to a shoulder fracture.The patient was a (b)(6) male.His right shoulder surgery was performed.Post-surgically, on (b)(6) 2018, the patient reported having a shoulder pain.The x-ray images were taken.It was found that the head of the reported device had been dislodged.On (b)(6) 2018, the reoperation was performed.The head and color were removed, and the head40x15 was replaced.It was brand new and the first use when the issue occurred.There was no delay in surgery and no harm to the patient.

• Brand Name: UNKNOWN SHOULDER HUMERAL BODY
• Type of Device: UNKNOWN SHOULDER HUMERAL BODY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7894416
• MDR Text Key: 120887683
• Report Number: 1818910-2018-69926
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2018

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 SHOULDER HUMERAL BODY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR