MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Catalog Number L20310

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Tissue Damage (2104); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 12/06/2017

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 received.Litigation alleges defective implant resulting to damage to patient¿s hip joint and body, pain and emotional distress.Doi: (b)(6) 2006; dor: not reported; right hip.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges loosening of stem, metal wear, metallosis, and elevated metal ions.

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: 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 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
=
> 2229001.Device history review
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> the dhr analysis of the batch indicated shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.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.

• Brand Name: CORAIL2 NON COL HO SIZE 10
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 7595698
• MDR Text Key: 110863600
• Report Number: 1818910-2018-61997
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L20310
• Device Lot Number: 2229001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 88