MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10; FEMORAL STEM

Model Number	3L92510
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp is reporting to nca/bfarm: "hip-tep right (b)(6) 2010 in neustadt.Always been satisfied with the hip-tep.Sudden onset of pain, no trauma, no triggering event.In the x-ray fracture of the prosthesis stem with clear loosening in the proximal area.Thereupon emergency presentation via our central emergency room.Hip-tep change right on (b)(6)2023." doi: (b)(6) 2010.Dor: (b)(6) 2023.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.
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).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.Initial reporter occupation: lawyer 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 and the provided x-ray evidence found the femoral stem fractured from the distal portion of the stem's body.However, the reported loosening allegation could not be confirmed without a series if x-rays to review.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed since the femoral head was still assembled on the stem and a valid lot number was not provided.
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 and the provided x-ray evidence found the femoral stem fractured from the distal portion of the stem's body.However, the reported loosening allegation could not be confirmed without a series if x-rays to review.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: 19-jun-2010.3) any anomalies or deviations identified in dhr: 1 part of this lot was scrapped, 9 parts from this lot were reprocessed and 1 non-conformances was associated with this lot.However, there is no correlation between these issues and the failure mode of the complaint.4) expiry date: jun-2015.5) ifu reference: w90942.Device history review: a manufacturing record evaluation was performed for the finished device [3l92510 / 3132685] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: CORAIL2 STD SIZE 10
• Common Device Name: 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 IN 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16477504
• Report Number: 1818910-2023-04928
• Device Sequence Number: 12575207
• Product Code: LZO
• UDI-Device Identifier: 10603295168768
• UDI-Public: 10603295168768
• 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: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/03/2023

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
• Device Model Number: 3L92510
• Device Catalogue Number: 3L92510
• Device Lot Number: 3132685
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 04/20/2023; 05/03/2023; 05/24/2023; 06/14/2023; 06/30/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/17/2023; 04/26/2023; 05/03/2023; 05/30/2023; 06/15/2023; 07/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2010
• 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: DELTA CER HEAD 12/14 36MM +8.5.; DELTA CER HEAD 12/14 36MM +8.5.; EA DELTA CER INSERT 36IDX54OD.; PINNACLE 100 ACET CUP 54MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male