MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-07-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine the legal contact information.(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

Pinnacle medical records received.After review of medical records the patient was revised to addressed failed left total hip arthroplasty secondary to metallosis.Operative notes indicated pain, trochanteric bursitis, muscle weakness, leg length discrepancy, erosion at the head and neck junction.Results for cobalt-chromium shows below 7ppb.Doi: (b)(6) 2010.Dor: (b)(6) 2020; (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, 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 device manufacturing (mre) review will not be performed even when product/lot information is known.Per wi-3430 it has been determined that, for the mom platform and related allegations an mre is not required.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+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: 11333544
• MDR Text Key: 232053918
• Report Number: 1818910-2021-03079
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033004
• UDI-Public: 10603295033004
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1365-07-000
• Device Catalogue Number: 136507000
• Device Lot Number: 2880671
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 03/11/2021
• Supplement Dates FDA Received: 02/23/2021; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+8.5; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM; TRI-LOCK BPS SZ 5 HI OFFSET; 12/14 ARTICUL 40MM M SPEC+8.5; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE SECTOR II CUP 56MM; TRI-LOCK BPS SZ 5 HI OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR