MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136505000

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pulmonary Embolism (1498); Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Weakness (2145); Injury (2348); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation is an attorney.

Event Description

Litigation alleged elevated levels of cobalt and chromium in his blood, joint effusion, pain, muscle damage, injury, and muscle weakness.Doi: (b)(6) 2007; dor: not reported; left hip.

Manufacturer Narrative

(b)(4).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 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.Additional narrative: udi: (b)(4).

Event Description

Ppf alleges pseudotumor, pulmonary embolism, dislocation with closed reduction, metal wear and metallosis.

Manufacturer Narrative

Product complaint # (b)(4).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 caused or contributed to the potential event described in this report.H10 additional narrative: added: a2(age), a3 b5, b7, and h6(patient).No code available use for medical device removal.

Event Description

Pfs alleges loss of function, psychological and emotional injury.After review of medical records patient was revised to addressed left hip adverse local tissue reaction from metal on metal hip replacement with instability, soft tissue loss, pseudotumor formation.Operative notes indicated significant amount of posterior capsular and short external rotator tissue loss.Deep within the acetabulum, there was a large cyst and was debrided.Added age, height and weight of patient and medical history.Doi: (b)(6) 2007 dor: (b)(6) 2018 left 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.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+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
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN ; UK
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 7828361
• MDR Text Key: 118615188
• Report Number: 1818910-2018-68059
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 136505000
• Device Lot Number: 2450408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 09/28/2018; 03/06/2019; 02/10/2020; 12/07/2021
• Supplement Dates FDA Received: 10/01/2018; 03/18/2019; 02/20/2020; 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2007
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG