MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 STD SIZE 8; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92507
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp reported to bfarm/nca: "the patient came to our emergency department on (b)(6) 2023 after referral by a resident colleague.She reported persistent left hip pain for several months after primary implantation of a hip-tep left side in 2012.No fall event known, exact period of the fracture could not be determined.Anyhow, a ct scan dated (b)(6) 2022 was available, here the femoral stem was still intact.After some time for reflection, the patient finally decided to have the damaged prosthetic component changed." doi: (b)(6) 2012.Dor: (b)(6) 2023.Affected side: left.
Additional 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 or Problem Description
Additional information received indicates that there was a surgical delay in the revision for about +45 minutes.
Additional 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device found the femoral stem fractured at the distal portion of the stem's body.No other defects were observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured:(b)(4) 2) date of manufacture: 20-july-2011 3) any anomalies or deviations identified in dhr: none 4) expiry date: june 2016 5) ifu reference: w90942 rev d device history review: a manufacturing record evaluation was performed for the finished device [3l92507 / 5101955] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: CORAIL2 STD SIZE 8
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17105954
• Report Number: 1818910-2023-12036
• Device Sequence Number: 2834210
• Product Code: LZO
• UDI-Device Identifier: 10603295168737
• UDI-Public: 10603295168737
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3L92507
• Device Catalogue Number: 3L92507
• Device Lot Number: 5101955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 07/25/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/20/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; HIP BALL BIOLOX 32 +1 12/14; PINN MAR NEUT 32IDX52OD; PINNACLE SECTOR II CUP 52MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female