MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Seroma (2069); Joint Dislocation (2374); Joint Laxity (4526)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical record received.After review of medical record patient was revised to address left prosthetic hip instability with recurrent dislocations.Patient experienced pain,and felt acute pop with obvious deformity.Surgeon felt an audible clunk.Patient underwent closed reduction on (b)(6) 2017 but failed with conservative treatment and proceed to revision surgery.Revision notes stated there was a seroma from the recent dislocation.Head and liner were removed.Doi: (b)(6) 2017 - dor: (b)(6) 2017 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis 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 : a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12069602
• MDR Text Key: 258700361
• Report Number: 1818910-2021-13627
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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 Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 5.0MM DIA TPRD HD PER SCRW 30; 5.0MM DIA TPRD HD PER SCRW 35; ALTRX +4 NEUT 36IDX52OD; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN DP REVSN W/GRIPTION 58MM; RECLAIM DISTAL TAPERED 16X140; RECLAIM PRX BDY CONE 24X85
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR