MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM HO 16; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Model Number	L98116
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when doing the x-ray control, the revision prosthesis has a tear in the distal part.It was high offset of 135ª.
Additional 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.
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 : no device associated with this report was received for examination.Examination in the provided x-ray and photos confirmed the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system was performed for the finished device [5365780] number, and no non-conformances were identified.
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.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 : device associated with this report was received for examination and found the implant was noted fractured at the medial aspect of the stem main body.With the information provided, a definitive potential cause could not be stablished.The device was analyzed by a metallurgist specialist and the findings conclusions are described as follows: "the hip stem was cyclically loaded beyond the material limit, resulting in fatigue crack initiation and propagation.The majority of the fracture surface exhibited fatigue characteristics, which is consistent with low stress high cycle fatigue as higher stresses would lead to a larger overload region.No material or manufacturing defects were observed in the titanium corail revision femoral stem that could have contributed to fracture initiation and/or propagation to failure.All evidence suggests the stem exhibited high strength and good ductility." 'see material evaluation attached under activity for details.' in order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional previous reports against the provided product code/lot code combination.A search of the depuy nonconformance (nc) quality system was performed for the finished device [5365780] number, and no non-conformances were identified.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot :a search of the depuy nonconformance (nc) quality system was performed for the finished device [5365780] number, and no non-conformances were identified.A search of the depuy nonconformance (nc) quality system was performed for the finished device [5365780] number, and no non-conformances were identified.

• Brand Name: CORAIL REVISION STEM HO 16
• Common Device Name: CORAIL KAR REVISION 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13250389
• Report Number: 1818910-2022-00711
• Device Sequence Number: 4432350
• Product Code: LZO
• UDI-Device Identifier: 10603295262442
• UDI-Public: 10603295262442
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: L98116
• Device Catalogue Number: L98116
• Device Lot Number: 5365780
• 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: 12/27/2021
• Supplement Date Received by Manufacturer: 01/24/2022; 01/24/2022; 03/14/2022; 04/20/2022; 09/07/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/01/2022; 02/14/2022; 03/15/2022; 04/27/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• 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: UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown