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

Model Number 1365-51-000

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

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 08/25/2017

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

Pinnacle litigation records received.Litigation alleges progressively worse pain, lack of mobility, emotional distress, metallosis and elevated metal levels of cobalt and chromium.Revision note reported, on the femoral side there was a significant degree of bone loss.There was a large black stained on mass on the lateral aspect of the greater trochanter, this was filled with metal debris.There was a pathologic fracture at the base of the greater trochanter.The acetabular component was grossly loose and there was pronounced metal staining of the remaining native acetabulum and surrounding soft tissues.There was almost complete loss of the anterior column and severe thinning of the posterior column.Radiograph shows some osteolysis with an area of lucency at the acetabular medial wall.Laboratory results for blood metal ion level shows above 7 ppb.Doi: (b)(6) 2008 : 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.

Event Description

Pfs alleges discomfort and fatigue.

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).

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.  .

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

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.Device history lot: a device manufacturing (mre) review will not be performed even when product/lot information is known.It has been determined that, for the mom platform and related allegations an mre is not required.

• 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 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7609156
• MDR Text Key: 111306984
• Report Number: 1818910-2018-62383
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/24/2018

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: 07/31/2013
• Device Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 2708173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 05/24/2018; 06/29/2018; 02/26/2019; 09/02/2019; 02/07/2022; 02/25/2022
• Supplement Dates FDA Received: 06/18/2018; 07/03/2018; 03/07/2019; 09/18/2019; 02/09/2022; 02/26/2022
• Date Device Manufactured: 07/26/2008
• 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
• Treatment: PINN SECTOR HA ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT DUOFIX TAP SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 61 KG