MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR 10D LNR 32IDX54OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 122032154

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that the required implant was not dispatched! case has been 3 months in preparation, surgeon has submitted tga sas forms to access implant.Implant specific details provided.Follow up with national scheduling performed.

Manufacturer Narrative

Product complaint # (b)(4).A delivery service issue was reported involving the special order for a given implant for revision surgery.The required product was not dispatched, and was unavailable for the procedure, the reporter indicated that this resulted in "catastrophic", unspecified patient consequences.This will be addressed as a serious injury, and additional follow-up is initiated to attempt to determine what were the actual consequences due to the product's unavailability.If new information becomes available, then the coding and reporting may be updated.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.

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 received: a.It was mentioned as ¿catastrophic effect to patient outcomes¿ ¿ could you please more information regarding the patient consequences! surgery was delayed for over 30mins whilst frail patient was on table b.How long was the surgical delay? 1.5 hours pre surgery and 30 mins intraoperatively c.Was the patient under anesthesia? if yes, how long ? yes, approximately 6 hours.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: DUR MAR 10D LNR 32IDX54OD
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18382931
• MDR Text Key: 331202507
• Report Number: 1818910-2023-25923
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295015543
• UDI-Public: 10603295015543
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K994415
• 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
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 122032154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention