MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136507000

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Scarring (2061); Test Result (2695); No Code Available (3191)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: reporter occupation: lawyer.(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 claim submission form and medical record received.After review of medical record, the patient was revised to address adverse local tissue reaction with synovitis.Revision notes reported that the hip capsule was scarred and was excised.The acetabulum was exposed and removed all the synovitis.There was some black debris in the trunnion then was cleansed and dried.Clinical visits reported pain, slight elevation in metal ions with significant inflammation in the iliopsoas tendon sheath.Additionally, it was noted that during the initial hip replacement, the femur fractured during implantation of the stem; the fracture was then stabilized with a cable.Doi: (b)(6) 2008; dor: (b)(6) 2018; (left hip).

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.Product complaint #
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> (b)(4).Investigation summary
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> 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: 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8740837
• MDR Text Key: 149397527
• Report Number: 1818910-2019-97014
• 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
• Report Date: 06/07/2019

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 Expiration Date: 02/28/2013
• Device Catalogue Number: 136507000
• Device Lot Number: 2557709
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR