MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 NON COL HO SIZE 18; HIP FEMORAL STEM

Model Number	L20318
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Within (b)(4) hcp reported a former revision of a ceramic hip head +9 because of instability under stem sintering of a corail stem.
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.H10 additional narrative: 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 and stated the following: the inlay was not revised in (b)(6) 2019.The hip stem was sintered preoperatively.Intraoperatively, there was no change in position or loosening of the stem.Revision only of the competitor´s hip head to another (longer) competitor´s hip head.There was no revision of the hip stem.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: dhr review details: 1) quantity manufactured: (b)(4).2) date of manufacture: 23 ¿ september - 2015.3) any anomalies or deviations identified in dhr: n/a.4) expiry date: 31-august-2020.5) ifu reference: w90942 rev.F.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.1) quantity manufactured: (b)(4), 2) date of manufacture: 23 ¿ september - 2015, 3) any anomalies or deviations identified in dhr: n/a, 4) expiry date: 31-august-2020, 5) ifu reference: w90942 rev.F.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Device history lot: dhr review details: 1) quantity manufactured: (b)(4), 2) date of manufacture: 23 ¿ september - 2015, 3) any anomalies or deviations identified in dhr: n/a, 4) expiry date: 31-august-2020, 5) ifu reference: w90942 rev.F.

• Brand Name: CORAIL2 NON COL HO SIZE 18
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16626519
• Report Number: 1818910-2023-06662
• Device Sequence Number: 19947740
• Product Code: LZO
• UDI-Device Identifier: 10603295258087
• UDI-Public: 10603295258087
• 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: 2017
• Device Explanted Year: 2018
• 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,Followup
• Report Date (Section B): 03/28/2023

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: L20318
• Device Catalogue Number: L20318
• Device Lot Number: 5257527
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/03/2023; 05/09/2023; 05/10/2023; 05/17/2023; 06/06/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/11/2023; 05/10/2023; 05/11/2023; 05/22/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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: CORAIL2 NON COL HO SIZE 18.; HIP BALL BIOLOX 32 +9 12/14.; PINN MAR NEUT 32IDX58OD.; PINNACLE SECTOR II CUP 58MM.; UNK ADAPTOR.; UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP FEMORAL HEAD CERAMIC.; UNK HIP FEMORAL HEAD CERAMIC.; UNK HIP FEMORAL STEM CORAIL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown