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

Catalog Number 136551000

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Anemia (1706); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Septic Shock (2068); Thrombosis (2100); Ambulation Difficulties (2544); Blood Loss (2597)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 21 aug 2017: litigation received.Litigation alleges friction and wear between the cobalt-chromium metal head and metal liner, pain, discomfort, inability to do adl, and elevated cobalt and chromium levels.It also alleges that revision findings reported "some serous fluid in the joint itself that did not appear purulent but was certainly inflammatory in nature.The tissue that was black and around the hip joint was meticulously dissected." there are no medical records and laboratory values provided.

Manufacturer Narrative

No device associated with this report was received for examination.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

No device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what were previously alleged, pfs alleges acute deep vein thrombosis associated with picc and requiring full-dose anticoagulation; acute blood loss anemia requiring 5 units blood transfusion; transfusion associated volume overload; large soft tissue hematoma requiring evacuation; wound infection secondary to septic shock; acute renal failure; left hip wound irrigation and debridement; removal of femoral head with exchange; follow up wound care for pain and wound drainage; and lifetime antibiotic treatment.

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 # (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 : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.Udi: (b)(4).

Event Description

Ppf alleges metallosis.

• 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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6877037
• MDR Text Key: 86652058
• Report Number: 1818910-2017-24941
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 136551000
• Device Lot Number: 2910705
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 10/17/2017; 12/12/2017; 01/12/2018; 03/29/2019; 12/03/2019
• Supplement Dates FDA Received: 10/18/2017; 12/28/2017; 01/17/2018; 04/15/2019; 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91