MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 12; HIP FEMORAL STEM

Model Number L20312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Scar Tissue (2060); Dizziness (2194); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Asr resurfacing litigation records received.After review of records, the plaintiff alleges pain, loss of balance, difficulty in walking, upset stomach, metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, dizziness, chronic fatigue, chronic pain, severe emotional and/or psychological distress relating to the pain and suffering and elevated metal ions.Doi: (b)(6) 2009.Dor: none reported.Unknown affected side.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: (b)(6).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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.

• Brand Name: CORAIL2 NON COL HO SIZE 12
• Type of Device: 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 INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17198489
• MDR Text Key: 317828627
• Report Number: 1818910-2023-12945
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258032
• UDI-Public: 10603295258032
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2023

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 Model Number: L20312
• Device Catalogue Number: L20312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 +1.5.; PINN CAN BONE SCREW 6.5MMX30MM.; PINNACLE MTL INS NEUT36IDX54OD.; PINNACLE SECTOR II CUP 54MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR