MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-720

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Foreign Body Reaction (1868)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reported on 15th march 2022; the patient had right hip arthroplasty surgery in (b)(6) 2021.After approximately two months, the patient reported hearing a ¿click¿ but continued to walk on the hip without seeking help at that time.The patient then complained that the hip was ¿squeaking¿ and sore and sought help.There was evidence of metallosis shortly after skin incision, the acetabular liner had dislocated from the acetabular shell and the ceramic head showed significant wear.The procedure was made considerably more complicated as the head was reportedly ¿stuck¿ in the liner and it was difficult to dislocate the hip.It was necessary to use a saw to make a cut on the liner for the purpose of levering the liner to dislocate the hip and remove the head.Please see photos attached to this email.New information as of today 27th may 2022: the patient was ¿doing well¿ at the six-week post operative check-up according to the physicians notes, but within a week, presented at clinic reporting a ¿clicking and grinding¿ sound and sensation, but no pain.A repeat x ray showed that the liner had disassociated, reason unknown.The physicians¿ notes suggest that there may be some ¿issue with the locking mechanism of the liner into the shell¿.On commencement today, there was metallosis in the joint, samples were sent for culture and sensitivity.The implants were successfully removed and alternate implants used.Please see attached x rays taken on (b)(6) 2022, prior to the dislocation of the liner from the cup and then on (b)(6) 2022, where the dislocation is evident.Please see attached images of the cup, liner and head which were removed.Doi: (b)(6) 2021; dor: (b)(6) 2022; right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available photo evidence were reviewed and it was observed that the femoral head have signs of wear as consequence of the disassociation between the cup and the liner.Additionally, it is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent the liner disassociation and does not signify any product error.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 : 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available photo evidence were reviewed and it was observed that the femoral head have signs of wear as consequence of the disassociation between the cup and the liner.Additionally, it is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.It is subsequent the liner disassociation and does not signify any product error.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 : 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 32MM +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: 14685257
• MDR Text Key: 293935314
• Report Number: 1818910-2022-10823
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033479
• UDI-Public: 10603295033479
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K073570
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-32-720
• Device Catalogue Number: 136532720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• 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
• Treatment: DLT TS CER HD 12/14 32MM +5; PINN MAR NEUT 32IDX52OD; PINN SECTOR W/GRIPTION 52MM
• Patient Outcome(s): Required Intervention