MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 9/10 ULTAMET 28MM HEADS + 3; HIP FEMORAL HEAD

Catalog Number 962702100

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Joint Dislocation (2374)

Event Date 08/23/2017

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

On (b)(6) 2009, tha surgery was performed using the following implants, and the surgery was successfully completed.Cup (mah: kyocera).Metal liner 46/28 (part#: 121889146, lot#: 2551325).Head 28mm+3 (part#: 962702100, lot#: unk).Stem (part# & lot#: unk).The patient received joint dislocation reduction twice in 2015, and twice in 2017.On (b)(6) 2017, revision surgery was performed to replace the cup, metal liner, and head with the following implants while the stem stayed left in the body because of its stable fixation.Cup (non-j&j: stryker dual mobility cup).Liner (part# & lot#: unk).Head (part# & lot#: unk).During the surgery, necrotic tissues were seen around the joint, and metal-worn or black materials were confirmed around the taper junction.The revision surgery was successfully completed with a 3-minute delay.The surgeon commented that this event might be caused by the repeated dislocation due to mom-induced armd.

Manufacturer Narrative

The patient received joint dislocation reduction twice in 2015, and twice in 2017.On (b)(6) 2017, revision surgery was performed to replace the cup, metal liner, and head with the following implants while the stem stayed left in the body because of its stable fixation.During the surgery, necrotic tissues were seen around the joint, and metal-worn or black materials were confirmed around the taper junction.The revision surgery was successfully completed with a 3-minute delay.The surgeon commented that this event might be caused by the repeated dislocation due to mom-induced armd.The reported event has been evaluated and will be monitored.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.

• Brand Name: 9/10 ULTAMET 28MM HEADS + 3
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6886618
• MDR Text Key: 87189174
• Report Number: 1818910-2017-25255
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 962702100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR
• Patient Weight: 40