MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136506000

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Injury (2348); Osteolysis (2377); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pinnacle claim letter received.Claim letter alleges injury and adverse metal debris.Doi: (b)(6) 2009 - dor: scheduled on (b)(6) 2019 (right hip).

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.

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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient code: no code available (3191) used to capture the code blood heavy metal increased patient and surgical intervention patient codes.

Event Description

Pinnacle mom claim letter and medical records received.Claim letter alleges injury, metallosis, pain and suffering.After review of medical records, it was indicated that the patient had elevated blood chromium and cobalt levels at 6.6 and 12.5 respectively.Patient also reports difficulty ambulating.There is an atypical fluid collection, multiple enlarged lymph nodes and a lesion noted on the mri report.X rays 1 month post-operation indicate that the right hip shows complete loss of joint space with cyst formation through both the acetabular area and femoral head.Patient also complains of unintentional weight gain, edema and trouble sleeping.The patient was then revised to address failure of the left total hip arthroplasty secondary to adverse reaction to metal debris.Intraoperative findings include a thick gray-white rind of necrotic tissue around the hip with a large pale gray cloudy effusion, moderate corrosion on the femoral head/trunnion interface and moderate osteolysis around the stem.

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

Event Description

Medical records and sticker sheets received.After review of medical records, there are no new allegations reported.It should be noted that the surgeon has indicated that there was no evidence of corrosion or abnormal wear involving the acetabular liner or shell.

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.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 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.H10 additional 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 will be filed as appropriate.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+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
• MDR Report Key: 8636240
• MDR Text Key: 146227238
• Report Number: 1818910-2019-94410
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K060031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/06/2019

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: 03/31/2014
• Device Catalogue Number: 136506000
• Device Lot Number: 2880667
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 05/29/2019; 07/02/2019; 07/09/2019; 12/26/2019
• Supplement Dates FDA Received: 06/07/2019; 06/13/2019; 07/09/2019; 07/11/2019; 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 120