MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

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

Patient Problems Fall (1848); Pain (1994); Osteolysis (2377)

Event Date 04/01/2020

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed slaven se, harrington cj, cody jp.Bilateral fractures of anatomic medullary locking hip arthroplasty stems in a single patient: a case report.J orthop case rep.2020;10(2):46-49.Doi: 10.13107/jocr.2020.V10.I02.1690.Pmid: 32953654; pmcid: pmc7476705.Objective and methods: stem fracture is a rare complication of total hip arthroplasty (tha) using fully porous-coated femoral stems.The purpose of this case study is to present bilateral fractures in a single patient have not been previously reported.A (b)(6) female underwent bilateral staged primary tha with fully porous-coated anatomic medullary locking femoral prostheses.She subsequently sustained stem fractures of her right and left prostheses in the 13th and 14th years after their implantation, respectively.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: bilateral thas consisting of and aml stem, pinnacle cup, and mom articulations adverse event(s) and provided interventions associated with depuy devices: right hip: (b)(6) male patient received primary right tha to treat end-stage osteoarthritis in (b)(6) 2003.Patient presented in (b)(6) 2015 with right thigh pain secondary to a fall.X-rays identify a stem fracture and femoral osteolysis.The patient¿s liner, head, and stem were revised to competitor products without complication.Left hip: (b)(6) female patient received a left primary tha to treat end-stage osteoarthritis in (b)(6) 2003.Patient presented in (b)(6) 2017 with left thigh pain and an x-ray in (b)(6) 2017 revealed left stem fracture and femoral cortical hypertrophy.The patient¿s liner, head, and stem were revised to competitor products without complication.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached images evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no finish goods lot number or product code was provided for this device.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• 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: 13994590
• MDR Text Key: 288615182
• Report Number: 1818910-2022-06049
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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 Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/13/2022
• 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: UNK HIP ACETABULAR CUP PINNACLE.; UNK HIP ACETABULAR LINER METAL.; UNK HIP ACETABULAR LINER METAL.; UNK HIP FEMORAL HEAD CERAMIC.; UNK HIP FEMORAL STEM AML.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female