MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 11; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Catalog Number	3L92501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
15 days first implantation: revision reported due to calcar fracture and acetabulum to medialzed.Doi: unknown.Doe: (b)(6) 2024.Affected side: left.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: b5, d4 (lot, expiration date), d6a, h4 corrected: d3, d4 (primary udi number), g1.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received states that there was no surgical delay.
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 that 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.
Event or Problem Description
Additional information was received: 1.Please clarify if the sticker sheet attached on 7/26 are the implants placed at revision.No they was removed this sticker are the implant that we have revised.2.If so - are they are any allegations against them.No.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information provided, it was reported that hip corail bi mentum left, 15 days first implantation calcar fracture acetabulum to medialsed.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.Visual analysis of the radiological image and photograph revealed no defects or evidence of a device nonconformance that could have contributed to the reported event were observed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the corail amt collar size 11 would not contribute to the reported adverse event.¿ 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 reported 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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: CORAIL AMT COLLAR SIZE 11
• Common Device Name: CORAIL AMT CEMENTLESS 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 IN 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19751015
• Report Number: 1818910-2024-15222
• Device Sequence Number: 6491462
• Product Code: LZO
• UDI-Device Identifier: 10603295168690
• UDI-Public: (01)10603295168690(17)280410(10)5546245
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3L92501
• Device Lot Number: 5546245
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 09/05/2024; 10/29/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/08/2024; 09/06/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: BI MENTUM PFRK PE LINER 28 51.; BI MENTUM PFRK PFIT CUP 51.; DELTA CER HEAD 12/14 28MM +8.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female