MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536730

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Fall (1848); Foreign Body Reaction (1868); Joint Dislocation (2374)

Event Date 09/18/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

It was reported that the patient had suffered a fall and dislocated the hip.Surgeon believed the poly may have dislodged from the cup following the fall.The poly had dislodged from the cup, so surgeon decided to replace with the same size poly and head since the patient's sizing had seemed to be correct after the first surgery.Time was not extended.The patient had metallosis in the hip from the head and liner rubbing on each other while the liner was out of the cup.Most of the wear looked to be from the ceramic head.Most of the pink coating from one side was worn off.Surgeon washed it out and replaced implants.Doi: (b)(6) 2021.Dor: (b)(6) 2023.Affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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: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.

• Brand Name: DLT TS CER HD 12/14 36MM +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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17840799
• MDR Text Key: 324548561
• Report Number: 1818910-2023-19766
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033677
• UDI-Public: 10603295033677
• 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
• Report Date: 09/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 136536730
• Device Lot Number: 9551275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX54OD.; UNKNOWN HIP ACETABULAR CUP.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male