MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136506000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Injury (2348); Test Result (2695); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

Pending metal on metal hip product liability.Litigation alleged injury, pain, blood heavy metal ions, emotional trauma and distress.Doi: (b)(6) 2009; dor: not reported; right hip.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Representing emotional distress.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4).

Event Description

Ppf alleges pseudotumor, metal wear and metallosis.

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.  .

Event Description

Pfs alleges loose of function, psychological and emotional injury.

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.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+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): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 7955782
• MDR Text Key: 123393115
• Report Number: 1818910-2018-72107
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/07/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: 136506000
• Device Lot Number: 2940239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 09/19/2018; 11/06/2018; 04/12/2019; 02/07/2020; 02/24/2022; 03/08/2022
• Supplement Dates FDA Received: 10/11/2018; 11/07/2018; 05/09/2019; 03/02/2020; 03/02/2022; 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male