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

Catalog Number L981310

Device Problem Fracture (1260)

Patient Problem Not Applicable (3189)

Event Date 06/27/2019

Event Type  malfunction  

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 Description

Surgeon put corail into the femur of patient after that he checked stability.He heard the sound from something like a crack/fracture during testing.He checked the patient and he saw some crack or corail stem.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 30mins.Action taken when event occurred? the surgeons tried to removed the corail but it can't remove.Was procedure successfully completed? yes.

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: following review of the information received, it was concluded that it was not possible to determine if a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.Device history lot: 8890789.Device history review: product code l981310, work order (b)(4) was manufactured on 12-october-2018.(b)(4) parts were manufactured per specification and all raw materials met specification.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 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.

• Brand Name: CORAIL AMT SZ10 135 LOW N COL
• Type of Device: 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: 8807015
• MDR Text Key: 151776328
• Report Number: 1818910-2019-98749
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295452546
• UDI-Public: 10603295452546
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: L981310
• Device Lot Number: 8890789
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 09/23/2019
• Supplement Dates FDA Received: 07/30/2019; 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR