MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ8 125 STD COL; CORAIL IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971208
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The stem inserter became stuck in the definitive stem.It wouldn't come out of the stem's tine when the surgeon tried to remove it and the entire definitive stem ended up being pulled out in the process.An osteotome was also used to try and remove the stem from the stem inserter.There was a burr which was identified on the end of the stem inserter after the case, it is unknown whether this was caused by the osteotome or if it was already there and was causing the stem inserter to get stuck.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 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.H11 additional narrative: added: a3a, b7.Corrected (g3) alert date.The correct alert date for this complaint is 7/02/2024 based on aei note a-11416016 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: according to the information received, "the stem inserter became stuck in the definitive stem.It wouldn't come out of the stem's tine when the surgeon tried to remove it and the entire definitive stem ended up being pulled out in the process.An osteotome was also used to try and remove the stem from the stem inserter.There was a burr which was identified on the end of the stem inserter after the case, it is unknown whether this was caused by the osteotome or if it was already there and was causing the stem inserter to get stuck." the product was not returned to depuy synthes; however, photos were provided for review.See attachment (b)(4).The investigation was not able to confirm the reported event as the complaint condition was represented clearly in the provided photo.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 records evaluation (mre) was not performed.
Event or Problem Description
Additional information received states that the procedure was completed successfully.
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.H11 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: CORAIL AMT SZ8 125 STD COL
• Common Device Name: CORAIL IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex IN 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 ; 3035526892
• MDR Report Key: 19722332
• Report Number: 1818910-2024-15051
• Device Sequence Number: 8130504
• Product Code: MEH
• UDI-Device Identifier: 10603295455387
• UDI-Public: (01)10603295455387(17)250430(10)9506813
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K192946
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: L971208
• Device Lot Number: 9506813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/20/2024; 08/06/2024; 10/22/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/07/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2020
• 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: ALTRX +4 NEUT 32IDX48OD.; APEX HOLE ELIM POSITIVE STOP.; DELTA CER HEAD 12/14 32MM +5.; PINN 100 W/GRIPTION 48MM.
• Patient Sex: Female