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

Model Number L20318

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Joint Laxity (4526)

Event Date 01/17/2018

Event Type  Injury  

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 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.

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 312102940
• Report Number: 1818910-2023-06662
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258087
• UDI-Public: 10603295258087
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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.
• Patient Outcome(s): Required Intervention