MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL HA W/O COLLAR S15 165MM; HIP FEMORAL STEM

Catalog Number L92515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Adhesion(s) (1695); Atrial Fibrillation (1729); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Thrombosis (2100); Tissue Damage (2104); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 10/13/2017

Event Type  Death  

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.Device was used for treatment, not diagnosis.This report is for an unknown hip femoral stem/unknown lot.Part and lot number are unknown; udi number is unknown.Initial reporter phone number listed as (b)(6).Initial reporter is an attorney (b)(4).

Event Description

Pending product liability reports: pinnacle mom litigation records received.Litigation alleges injury, metallosis and elevated cobalt level.The procedure involved the left hip.The date of implant was (b)(6) 2005 and a date of revision was (b)(6) 2017.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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, a follow-up medwatch will be filed as appropriate.

Event Description

Ppf and implant stickers received.In addition to what were previously alleged, ppf alleges psuedotumor and metal wear.(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.  added b5 and b7.Corrected: h6 (patient).H6 patient code: no code available (3191) used to capture blood heavy metal increased, medical device removal and surgical intervention patient codes.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.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, 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 caused or contributed to the potential event described in this report.H10 additional narrative: udi: (b)(4).Added: a2(dob, age), a4, b5, b6, b7, d1, d2, d4(product and lot number), and h6 (patient).

Event Description

Pfs alleges pain, right deep vein thrombosis with pulmonary embolism, atrial fibrillation and sequelia.After review of medical records patient was revised to addressed irrigation and debridement., periprosthetic joint infection.Revision notes indicated removal of scar tissue around the cup, a gross purulence was observed within the joint space as well as medial to the obturator.Added medical history, demographic data of patient, product details of liner, head and stem.Also added cup and screw due to new allegation.Corrected patient's initial.Doi: (b)(6) 2005 dor: (b)(6) 2017 left hip.

• Brand Name: CORAIL HA W/O COLLAR S15 165MM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 8304633
• MDR Text Key: 134990402
• Report Number: 1818910-2019-83244
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L92515
• Device Lot Number: 1818441
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/13/2019; 01/10/2020; 01/20/2020; 01/28/2020
• Supplement Dates FDA Received: 02/15/2019; 01/10/2020; 01/23/2020; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 113