MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92502

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problems Foreign Body Reaction (1868); Hematoma (1884); Necrosis (1971); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Limb Fracture (4518); Unspecified Tissue Injury (4559)

Event Date 07/27/2010

Event Type  Injury  

Event Description

New etq created in order to update etq (legacy system) complaint number: (b)(4).Reason for original complaint- litigation alleges that patient experienced severe pain and discomfort in his right hip and groin.Update rec'd - sales rep reported revision surgery.Only the femoral head and stem were revised on (b)(6) 2010.Patient's liner was revised to address pain and metallosis.Invoice was located providing part/lot information.The information received does not change the mdr decision.Update ad on (b)(6) 2018: (b)(4) has been re-opened under (b)(4) due to receipt of ppf and implant records.In addition to what were previously alleged, ppf alleges loosening of cup and metal wear.Added account name, facility name, associated contact, age, impacted products (cup and screw).Updated patient identifier.Dor: on (b)(6) 2010 - dor: on (b)(6) 2010 (head, cup and screw), on (b)(6) 2014 (liner); (right hip).

Manufacturer Narrative

Product complaint #: (b)(4).Upon review "medical records patient was revised was due to periprosthetic femur fracture.Operative notes indicated some exudate type of material around femoral.Cleaned out the fracture hematoma, cancellous loose bone, any debris from prosthesis.It is reasonable to attribute the patients hematoma and cancellous loose bone to the periprosthetic femur fracture.The femoral stem is being reported to cover the fracture, as that is the only implant that comes into direct contact with the femur." for allegations after 1st revision of the right hip, see related pc.1.The pinnacle mtl ins neut36idx52od component was reported on report number 1818910-2012-09788.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.2.The articuleze m head component was reported on report number 1818910-2012-09789.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.3.The pinnacle sector ii cup 52mm component was reported on report number 1818910-2019-93184.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.4.The pinn can bone screw 6.5mmx25mm component was reported on report number 1818910-2019-93183.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.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.

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: h6 unspecified tissue injury (e2015) utilized to capture soft tissue injury & bone injury.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; the device associated with this report was not returned to depuy synthes for evaluation.Review of the x-ray evidence was not able to confirm the complaint.No signs of device movement from original placement were identified.Nothing indicative of a device malfunction was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records (mre) was not performed.

• Brand Name: CORAIL AMT COLLAR SIZE 12
• 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 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15713938
• MDR Text Key: 302837542
• Report Number: 1818910-2022-21838
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168683
• UDI-Public: 10603295168683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2022

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
• Device Operator: Health Professional
• Device Model Number: 3L92502
• Device Catalogue Number: 3L92502
• Device Lot Number: 5021834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 12/02/2022; 03/09/2023
• Supplement Dates FDA Received: 12/05/2022; 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2010
• 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
• Treatment: ARTICULEZE M HEAD 36MM +12.; CORAIL AMT COLLAR SIZE 12.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE MTL INS NEUT36IDX52OD.; PINNACLE SECTOR II CUP 52MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 101 KG