MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; HIP FEMORAL HEAD

Catalog Number 136552000

Device Problem Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994); Rash (2033); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Injury (2348); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Not Applicable (3189)

Event Date 08/08/2017

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

Pinnacle litigation received.Litigation alleges pain, discomfort, stiffness, soreness, inability to perform dla, friction and wear, toxic metal ions and particles, revision findings of gray cloudy fluid consistent with metallosis.Doi: (b)(6) 2009; dor: (b)(6) 2017; left hip.

Manufacturer Narrative

(b)(4).

Event Description

Pfs and medical records received.Pfs alleges poor memory, mental fogginess, kidney and bladder infections, tremors and skin rashes.After the review of medical records for mdr reportability, it was stated that the patient was revised to address pain and metallosis.Revision notes reported that there was a cloudy fluid that was stained gray, excessive bleeding in the wound, drop in blood pressure and weakness.There were no significant lab results provided.Doi: (b)(6), 2009; dor: (b)(6), 2017; 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. .

Manufacturer Narrative

Udi: (b)(4).

• Brand Name: ARTICULEZE M HEAD 36MM +5
• Type of Device: HIP FEMORAL HEAD
• 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 LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 7184805
• MDR Text Key: 97049658
• Report Number: 1818910-2018-50974
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2014
• Device Catalogue Number: 136552000
• Device Lot Number: 2956036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2018
• Date Device Manufactured: 07/13/2009
• 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 Age: 70 YR
• Patient Weight: 87