MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 9; HIP FEMORAL STEM

Model Number	L20309
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	07/20/2020
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.
Event or Problem Description
Reason for revision: loose stem.On (b)(6) 2020, stem and articuleze head were removed and replaced with a stem and head from another company.Marathon liner was changed, and acetabular h/e pos stop screw was replaced with a hole eliminator.Original operation conduced by the surgeon in 2006.Patient demographics.(b)(6) caucasian male.Surgeon stated stem was undersized in original operation and had become loose.No infection.
Additional 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.
Additional 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.H10 additional narrative: added: d4 (lot).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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 code(s) 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.Corrective action was not indicated.The complaint was received into the company with the following comment: reason for revision: loose stem.On (b)(6)2020, stem and articuleze head were removed and replaced with a stem and head from another company.Marathon liner was changed, and acetabular h/e pos stop screw was replaced with a hole eliminator.Original operation conduced by the surgeon in 2006.Patient demographics.61 year old caucasian male.X rays attached.Surgeon stated stem was undersized in original operation and had become loose.No infection.X rays were provided and when reviewed, no product defects were noted.The surgeon has commented that the stem was undersized in the original procedure.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 code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.As no device has been returned to this point, a physical analysis of the product is not possible.Should the device be returned, the investigation will be reopened and investigated accordingly.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: d5.Corrected: g1.H6 patient code: insufficient information reported in the initial medwatch is being retracted.

• Brand Name: CORAIL2 NON COL HO SIZE 9
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10338887
• Report Number: 1818910-2020-17112
• Device Sequence Number: 12288936
• Product Code: KWA
• UDI-Device Identifier: 10603295258001
• UDI-Public: 10603295258001
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: L20309
• Device Catalogue Number: L20309
• Device Lot Number: 1822350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 08/21/2020; 09/28/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/04/2020; 09/03/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; PINN MAR +4 10D 32IDX56OD; APEX HOLE ELIM POSITIVE STOP; ARTICUL/EZE BALL 32 +1 GR; PINN MAR +4 10D 32IDX56OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR