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

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Discomfort (2330); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Clinical symptoms code: appropriate term/code not available (e2402) used to capture blood heavy metal increased.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

Pinnacle medical records.After review of medical records patient was revised to addressed pain, discomfort, injury, elevated cobalt and chromium levels, metallosis, a 2 cm x 2 cm cystic lesion filled with gray material on the superior acetabulum and around the stem posterior aspect.Clinic visits reported of bursitis, squeaking, leg length discrepancy and wear debris.Doi: (b)(6) 2008, dor: (b)(6) 2019, right hip 1st revision.

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 : per wi-3430 it has been determined that should related reports be identified a dhr review is not required.

• 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
• MDR Report Key: 10991699
• MDR Text Key: 220931587
• Report Number: 1818910-2020-26792
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

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: 2620983
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT POR TAPER SZ6 STD OFF; APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; PINNACLE 100 ACET CUP 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT POR TAPER SZ6 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 83