MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROTRUSIO CAGE 48ODX45ID R; MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES

Model Number 1011-85-000

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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

Clinical adverse event received for failure of the protrusio cage with acetabular fracture : migration/loosening - polyethylene shell -- inferior tang of cage has fractured and separated, superior tang is intact.The posterior place has also fractured.Greater troch is butted up against the pelvic iliac wing, hip itself is located event is not serious and is considered moderate event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2019.Date of revision: (b)(6) 2019 (cup, liner, femoral head, to address a pelvic bone fracture).Date of event (onset): (b)(6) 2021.(right hip).(b)(6) 2021 medical records note the patient is 2 years out from revision surgery for her protrusion and both column acetabular fracture.The patient has a failed cage, it migrated into the pelvis.The patient continues to have a nonunion of her bi-column fracture and failure of her cage.At this time there was no invasive treatment.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.Provided x-rays have been reviewed confirming the reported material fracture.It is understood this device, and additional unknown fracture/trauma product was used to repair an earlier pelvic bone fracture for this patient.Patient bone condition and not device error is suspected to be the contributing factor.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PROTRUSIO CAGE 48ODX45ID R
• Type of Device: MISCELLANEOUS JOINT IMPLANTS : HIP ACETABULAR CAGES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12215322
• MDR Text Key: 263397067
• Report Number: 1818910-2021-15816
• Device Sequence Number: 1
• Product Code: JDJ
• UDI-Device Identifier: 10603295000655
• UDI-Public: 10603295000655
• Combination Product (y/n): N
• PMA/PMN Number: K962007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-85-000
• Device Catalogue Number: 101185000
• Device Lot Number: 348034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX48OD.; ARTICUL/EZE BALL 32 +1 GR.; CEMENTRALIZER 13.0.; DEPUY CMW 1 40G.; DEPUY CMW 2 20G.; DEPUY/CMW 2G.; DEPUY/CMW 2G.; PINN CAN BONE SCREW 6.5MMX15MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PROTRUSIO CAGE 48ODX45ID R.; SLF TAPPING ROOF PILE SCRW15MM.; SLF TAPPING ROOF PILE SCRW15MM.; SLF TAPPING ROOF PILE SCRW20MM.; SLF TAPPING ROOF PILE SCRW25MM.; SLF TAPPING ROOF PILE SCRW25MM.; SLF TAPPING ROOF PILE SCRW30MM.; SLF TAPPING ROOF PILE SCRW30MM.; SUMMIT CEMENTED STEM SZ6 HI.
• Patient Age: 77 YR
• Patient Weight: 61