MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CERAMAX CERAMIC INSERT 28 X 48; HIP ACETABULAR LINER

Catalog Number 121889648

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 09/16/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

The investigation is ongoing.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

While dr (b)(6) was performing a rth on this patient, he reamed and implanted a 48mm cup.Dr (b)(6) asked for and chose to implant a ceramax ceramic insert.He said the insert was lined up perfectly and when he went to impact the liner it shattered into pieces.All pieces were retrieved as best as it could be and will be returned to depuy.He also removed the cup and inserted a new one.A poly insert was impacted.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the returned devices by the manufacturing supplier confirms the reported material fracture.The root cause is attributed to inadvertent user error.The density of the insert was analyzed and found to be complying with the delivery specification for biolox®delta components.The microstructures as obtained from the quality documents of both parts accomplish the requirements as specified at the time of production, too.There are no indications of any pre-existing material defect.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.Erratic secondary metal transfer patterns as a result of contact with metal parts during the surgery can be found on the insert.Primary regular metal transfer cannot be found on the insert.The existing metal transfer on the transition i/j indicates a misaligned position of the insert in the metal shell.On the upper taper of the metal shell two inclined scratches can be found.These scratches indicate a misaligned position of the insert in the metal shell.Due to the misalignment there were point contacts between the metal shell and the insert which initiated the fracture.Based on the performed investigation the need for corrective action has not been indicated.

• Brand Name: CERAMAX CERAMIC INSERT 28 X 48
• Type of Device: HIP ACETABULAR LINER
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4114537
• MDR Text Key: 12208240
• Report Number: 1818910-2014-28765
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 121889648
• Device Lot Number: 5355204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 103