MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Fall (1848); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

(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

Litigation and medical records received and 11 may 2022.

Event Description

On (b)(6) 2018, (b)(6) 2018) the patient had a right total hip arthroplasty, to address right hip degenerative joint disease.Depuy components were used during this procedure.Physical therapy notes report that on (b)(6) 2018, patient admitted to hospital x3 days related to fatigue, mild confusion, elevated wbc¿s, place don iv antibiotics.Recurring fevers and leukocytosis, hip effusion, right, the patient had a ct aspiration of right hip to address right hip effusion on (b)(6) 2018, the patient reports having falling on wet floor, pain and difficulty walking.On (b)(6) 2021, (b)(6) 2021) the patient underwent a revision, anterior right total hip replacement to address failed right total hip replacement, disengagement of polyethylene liner, spin out.The indications for surgery including pain and squeaking of the right hip.During the procedure the surgeon reported finding a fractured disengaged polyethylene liner, well-fixed acetabular component, well-fixed femoral component.The surgeon reported that there was no obvious insufficiency of the locking mechanisms, however, ¿this could be microscopic¿.The femoral head had a wear stripe from articulation against the acetabular component.The cup, liner, head, and 1 screw were removed.Depuy components were implanted in this procedure.

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, 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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: b5, e3.E3 initial reporter occupation: lawyer.

• Brand Name: DELTA CER HEAD 12/14 32MM +1
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14590609
• MDR Text Key: 293252387
• Report Number: 1818910-2022-10014
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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: 1365-32-310
• Device Catalogue Number: 136532310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 07/06/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 32IDX50OD; CORAIL AMT COLLAR SIZE 10; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female