MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136553000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial 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

After review of medical records, the patient was revised to address pain and instability with evidence of metallosis and cystic pseudotumor.Operative findings include 500 cc of brown/black fluid and adverse tissue reaction throughout the hip joint.It was also reported that patient previously had frank dislocations and sensations of subluxation.Clinic visits reported discomfort, limited mobility and walking difficulty.Lab results provided shows metal ion levels below 7ppb.Doi: (b)(6) 2007 - dor: (b)(6) 2018, (left hip).

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 8687035
• MDR Text Key: 147598279
• Report Number: 1818910-2019-95672
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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: 06/30/2012
• Device Catalogue Number: 136553000
• Device Lot Number: 2399945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2007
• 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: 60 YR
• Patient Weight: 107