MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL CEM STEM STD S12; CORAIL AMT CEMENTED IMPLANTS : HIP FEMORAL STEM

Catalog Number L96412

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/07/2017

Event Type  Injury  

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

Fracture.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL CEM STEM STD S12
• Type of Device: CORAIL AMT CEMENTED IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 21512 -6; FR 21512-6
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8054831
• MDR Text Key: 126651565
• Report Number: 1818910-2018-75054
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: L96412
• Device Lot Number: D17050903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR