MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 LAT COXA VARA SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number 3L93713

Device Problem Fracture (1260)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Scarring (2061); Weakness (2145); Hypoesthesia (2352); No Code Available (3191)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's femur component broke at the neck, and the patient's femur bone fractured while removing the implant.

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records the patient was revised to address fracture of the trunnion and head and instability.It was also reported that the patient had neurologic dysfunction, numbness, weakness in his sciatic distribution, plantar and dorsiflexors of the left foot, fracture head was removed and the remaining trunnion from acetabulum.Revision note reported extensive scarring and overall and non paliable tissues both above and below fascia, noted a pedestal at the tip of the former femoral stem.

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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Claim letter received.Claim letter alleges that patient had a catastrophic failure of the left femoral component trunnion, requiring revision and extensive trochanteric osteotomy.

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.H6 patient code: no code available (3191) used to capture the device revision or replacement and joint instability.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.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.Device history lot : 5226172.Device history review : a device history record (dhr) review was performed.The dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there was no deviation or non-conformance.

• Brand Name: CORAIL2 LAT COXA VARA SIZE 13
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 69801 ; FR 69801
• MDR Report Key: 7948107
• MDR Text Key: 123114166
• Report Number: 1818910-2018-71817
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3L93713
• Device Lot Number: 5226172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 10D 40IDX58OD; PINNACLE MULTIHOLE II CUP 58MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR