MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +5.0; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136536720

Device Problem Noise, Audible (3273)

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

On (b)(6) 2017 states the patient is having right hip pain with popping and grinding (crepitus) when exercising.Patient was diagnosed with right greater trochanter bursitis and was given a cortisone injection.On (b)(6) 2017, he continues to have mild pain with palpation over the right greater trochanter but only recommended intervention is stretching and ice.On (b)(6) 2018, he continues to have mild pain over the right greater trochanter after extended walking and will continue stretches and ice.On (b)(6) 2021, the patient states he has pain and swelling in his right hip and is treating with ice and tylenol.On (b)(6) 2022, an ultrasound shows a large fluid collection in the area of the trochanteric bursa.Aspiration and possible physical therapy is considered though no notes indicate the aspiration occurred.(b)(6) 2022, patient undergoes a serious of physical therapy treatments for the ongoing swelling and pain over the right hip.Doi: (b)(6) 2013; dor: unrevised; right hip.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary
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> 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.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.

• Brand Name: DLT TS CER HD 12/14 36MM +5.0
• 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: 17602616
• MDR Text Key: 321728473
• Report Number: 1818910-2023-17252
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295033660
• UDI-Public: 10603295033660
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136536720
• Device Lot Number: 3538577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2012
• 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: AML LG STATURE 13.5MM.; PIN LNR CONS NEUT +4 36IDX58OD.; PINNACLE 100 ACET CUP 58MM.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White