MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-53-000

Device Problem Noise, Audible (3273)

Patient Problems Hematoma (1884); Nerve Damage (1979); Pain (1994); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 02/09/2022

Event Type  Injury  

Event Description

Clinical notification received for revision of hip to address periprosthetic femur fracture.Date of implantation: (b)(6) 2021; date of revision: (b)(6) 2022; (left hip).Treatment: revision of femoral stem, femoral head, and acetabular liner.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available x-rays were reviewed, and there is no enough information that can determine the relationship of the device to the reported event.Complaint is not confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13860479
• MDR Text Key: 287673258
• Report Number: 1818910-2022-05176
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

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: 1365-53-000
• Device Catalogue Number: 136553000
• Device Lot Number: 9845346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• 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: ARTICULEZE M HEAD 36MM +8.5; PINN MAR +4 NEUT 36IDX56OD; SUMMIT STEM POROCOAT HIGH OFFSET SZ 7
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White