MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL REVISION STEM HO 13; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Catalog Number	L98113
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Scarring (2061); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional 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.Patient code: surgical intervention.
Event or Problem Description
The corail revision prosthesis has been broken a couple of weeks/months after surgery.
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Event or Problem Description
The corail revision shaft is broken after a few weeks, within 3 months after surgery.
Additional 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.
Event or Problem Description
Medical records received.After review of medical records, it was reported that the patient was revised to address fracture of the stem causing pain, leg length discrepancy and component loosening.Operative notes reported of neocapsule scarring and massive loosening was apparent which was pulled out with the bare hand.
Additional 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.Investigation summary: examination of the device confirmed the device had fractured.No anomalies in manufacturing records or complaint databases.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: 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.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.
Additional 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: examination of the device confirmed the device had fractured no anomalies in manufacturing records or complaint databases.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: he 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.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.

• Brand Name: CORAIL REVISION STEM HO 13
• Common Device Name: CORAIL KAR REVISION IMPLANT : 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: 7938250
• Report Number: 1818910-2018-71449
• Device Sequence Number: 931053
• Product Code: LWJ
• UDI-Device Identifier: 10603295262411
• UDI-Public: 10603295262411
• Combination Product (Y/N): N
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/13/2018

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
• Operator of Device: No Information
• Device Catalogue Number: L98113
• Device Lot Number: 5277178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 11/15/2018; 12/18/2018; 03/20/2019; 11/04/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/05/2018; 11/19/2018; 12/20/2018; 03/22/2019; 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR