MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DELTA CER HEAD 12/14 32MM +1; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-310

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Edema (1820); Pain (1994); Discomfort (2330); Joint Disorder (2373); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 07/13/2019

Event Type  Injury  

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

A review of the provided video link is able to identify a loud audible squeaking noise as the patient bends and straightens the left leg.

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.(b)(4).

Event Description

Patient mag underwent left hip total arthroplasty surgery due to genetic malformation.On (b)(6) 2017, the patient underwent surgery for insertion of the prosthesis in the left hip.After the aforementioned surgery, the patient presented an excellent evolution and recovery, with no complications until (b)(6) 2019.It happens that, on (b)(6) 2019, the patient, for no apparent reason, presented a sudden pain and functional disability of the previously operated hip, which is why she informed the doctor in charge of her surgery, who advised her to go immediately to (b)(6) hospital, where the first surgery had taken place.According to a medical report provided by the same professional who performed both surgeries, after analyzing clinical and imaging examinations, it was found that urgent surgery was necessary, as there was a subluxation of the femoral component head, unsuccessfully attempting a ¿bloodless reduction¿.¿as the material presented gross instability, that is, a displacement of the prosthesis was found and a replacement was attempted, but as the instability remained, a revision of the arthroplasty was indicated, requiring the replacement of the prosthesis.On (b)(6) 2019, surgeon underwent the second surgery in which, to his surprise, a fracture / rupture of the polyethylene was found, that is, the prosthesis had ruptured inside her body, so the pain, as well as instability and the functional disability suddenly suffered by it.The patient, up to the date of hospitalization, had a good adaptation to the prosthesis, not having suffered any fall, impact, accident, anything that would justify the rupture of such a resistant material.Which should last at least 30 years and ruptured in just 2 years.As there is a period of adaptation of approximately 3 (three) months from the organism to the prosthesis, on (b)(6) of the current year, the second prosthesis left the place, which resulted in a second hospitalization of 1 (one) day for the relocation of the prosthesis.The ruptured prosthesis, removed during the second surgery, was discarded by the hospital.

Event Description

English translation of original source file received.This is a claim letter which letter alleges pain, functional disability, subluxation of the head which was initially treated with a closed reduction but failed due to the instability, and displacement.There was also some medical records provided which indicate that during the revision, a breakage of the polyethylene insert was discovered while the implant was still inside the patient.There was also liquid collection that was sent for culture.The stem was noted to be broken/damaged.The claim further alleges emotional shock, physical and psychological pain, limb asymmetry, scars, discomfort, difficulty in moving around and in performance of daily activities.Doi: (b)(6) 2017 - dor: (b)(6) 2019 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added b5 and h6 (patient codes).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H6 patient code: no code available (3191) used to capture the patient code device revision or replacement and limb asymmetry.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9565303
• MDR Text Key: 184929352
• Report Number: 1818910-2020-01111
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033431
• UDI-Public: 10603295033431
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 1365-32-310
• Device Catalogue Number: 136532310
• Device Lot Number: 8361785
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR