MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 40MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136540730

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that patient had a 40 +8.5 head implanted.Patient had a 36 liner implanted.Patient brought back to surgery to remove 40 +8.5 head and change to 36+8.5.It was unknown, if there was a surgical delay.Doi- (b)(6) 2024.Dor- (b)(6) 2024.Affected side- unknown hip.

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.

Event Description

Additional information received: a.Was there a surgical delay? if yes, what is the duration of the delay? -no surgical delay.B.What is the affected side involved in this event? -left side.C.What was the reason for removal/ revision surgery? -switch head size due to instability.D.Please provide the product details of unknown hip acetabular liners -liner was not revised.

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: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 health effect - clinical code.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A manufacturing record evaluation (nc search) was performed, for the finished device product code: 136540730, lot#: 4208587.And no non-conformances/manufacturing irregularities were identified.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.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation (nc search) was performed, for the finished device product code: 136540730, lot#: 4208587.And no non-conformances/ manufacturing irregularities were identified.

• Brand Name: DLT TS CER HD 12/14 40MM +8.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18895802
• MDR Text Key: 337570407
• Report Number: 1818910-2024-05700
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033714
• UDI-Public: 10603295033714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 136540730
• Device Lot Number: 4208587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/22/2024; 03/25/2024
• Supplement Dates FDA Received: 03/25/2024; 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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: UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female