MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL AMT SZ10 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971110
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: delta cer head 12/14 32mm +5 femoral head; unknown hip acetabular liner; unknown hip acetabular cup; corail amt sz10 135 high col femoral stem.
Event or Problem Description
X-ray is attached.Patient originally had a total hip replacement on (b)(6) 2017 and the original implants are as follows: ref: l971110 (to be returned), lot: 8328858, description: sz10 ho collared corail stem; ref: 121731052 (implanted), lot: c28818, description: 52mm gription 100; ref: 121932052 (implanted), lot: 728810, description: 32mm x 52mm neutral liner; ref: 136532320 (to be returned), lot: 8417808, description: +5 32mm delta ceramic head; ref: 124603000 (implanted), lot: d16102057, description: hole eliminator.Patient presented to a&e with pain - no trauma - just been walking.Fractured femoral stem implant.Distal fragment was very well fixed/bonded - had to be removed with trephines.Proximal fragment came out easily and still has ha coating on.We have removed the femoral stem but left the acetabular implants in situ.
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
Difficult to remove distal fragment due to how well it had bonded to the host bone.With the use of trephines and k-wires (as per surgical technique for stem removal) it probably added about 1 hour to the procedure to remove the distal fragment.
Additional 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
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.
Additional Manufacturer Narrative
H10 additional narrative: corrected: h6 product complaint # = > pc-(b)(4).Investigation summary = > the devices were reviewed by applied research and bioengineering and a report was received stating; it is unlikely that a potential product issue was present.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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot = > dhr review product code l971110, work order 8328858 was manufactured on 12/jul/16.10 parts were manufactured per specification and all raw materials met specification.2 part were scrapped from work order 8328858.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.

• Brand Name: CORAIL AMT SZ10 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : 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: 7850196
• Report Number: 1818910-2018-68527
• Device Sequence Number: 11182074
• Product Code: KWA
• UDI-Device Identifier: 10603295455295
• UDI-Public: 10603295455295
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/09/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: L971110
• Device Catalogue Number: L971110
• Device Lot Number: 8328858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 11/28/2018; 01/22/2020; 03/19/2020
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/08/2018; 11/28/2018; 02/21/2020; 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention