MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-310

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

Patient Problems Wound Dehiscence (1154); Seroma (2069)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.(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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Device history batch: null.Device history review: null.

Event Description

Patient was revised due to dehiscence of incision with seroma.There was no surgical delay.Doi: (b)(6) 2022; dor: (b)(6) 2022; affected side: left hip.

• Brand Name: DELTA CER HEAD 12/14 36MM +1.5
• 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15437293
• MDR Text Key: 300035232
• Report Number: 1818910-2022-18030
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: 10603295033615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• 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
• Report Date: 09/16/2022

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 Model Number: 1365-36-310
• Device Catalogue Number: 136536310
• Device Lot Number: 3803128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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: ALTRX +4 NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +1.5
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 100 KG