MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136551000

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Necrosis (1971); Pain (1994); Tissue Damage (2104); Anxiety (2328); Discomfort (2330); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

(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.(b)(4).

Event Description

Pinnacle claim and medical records received.After review of claim and medical records, it was stated that the patient was revised due to dislocation with adverse tissue reaction due to mom prosthesis possible infection resulting to pain, walking difficulty and anxiety.Operative notes reported purulent looking joint fluid, tissue loss, discolored tissues and adverse local tissue reaction with metal debris.Clinical visit reported pain, fall, infection due from metal debris, leg length discrepancy, periprosthetic fracture with orif, bursitis, clicking, discomfort, cysts, avascular necrosis and subluxation of the femoral head.Lab result for culture reported no acid fast bacilli seen, no fungus recovered and no organism seen.Doi: (b)(6) 2010; dor: (b)(6) 2018; right 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.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 +1.5
• 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, IN 19380-0988 ; 6103142063
• MDR Report Key: 8544139
• MDR Text Key: 142894906
• Report Number: 1818910-2019-91455
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• 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: 04/02/2019

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: 01/31/2015
• Device Catalogue Number: 136551000
• Device Lot Number: 3063295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2010
• 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: 74 YR