MAUDE Adverse Event Report: DEPUY INTL., LTD. 8010379 ARTICULEZE M HEAD 36MM +8.5; HIP FEMORAL HEAD

Catalog Number 136553000

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Swelling (2091); No Code Available (3191)

Event Date 09/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Maude report mw5057662 states: failed right total hip arthroplasty secondary to adverse reaction to metal debris and pseudotumor.

Manufacturer Narrative

Maude report mw5057662 states: failed right total hip arthroplasty secondary to adverse reaction to metal debris and pseudotumor.No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd 01/04/2016, 01/11/2016, 01/19/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records the patient had a large pseudotumor from the posterior and anterior hip that was removed, elevated cobalt and chromium levels, obvious metal debris in the joint, and notching on the posterior aspect of the femoral head due to over-anteversion of his acetabular component.At this time the patient's femoral stem and acetabular cup are being added to the complaint and reported.The complaint was updated on: 01/20/2016.

Manufacturer Narrative

Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update rec'd 01/26/2016 - medical records received.After review of the medical records for mdr reportability, part/lot information was given for unknown depuy stem.Part/lot updated.The complaint was updated on: feb 23, 2016.

Manufacturer Narrative

Maude report mw5057662 states: failed right total hip arthroplasty secondary to adverse reaction to metal debris and pseudotumor.No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5255098
• MDR Text Key: 32318750
• Report Number: 1818910-2015-36071
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2009
• Device Catalogue Number: 136553000
• Device Lot Number: 1187141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2004
• 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 Age: 79 YR
• Patient Weight: 98