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 Problems Foreign Body Reaction (1868); Discomfort (2330)

Event Date 03/15/2022

Event Type  Injury  

Event Description

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. Doi: (b)(6) 2021; dor: (b)(6) 2022; right hip.

Manufacturer Narrative

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

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13965461
• MDR Text Key: 288287329
• Report Number: 1818910-2022-05866
• Device Sequence Number: 1
• Product Code: KWA
• 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
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1365-32-720
• Device Catalogue Number: 136532720
• Device Lot Number: 4541256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/31/2022 Patient Sequence Number: 1

Treatment

DLT TS CER HD 12/14 32MM +5; PINN MAR NEUT 50ODX32ID; UNKNOWN HIP ACETABULAR CUP