MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ASR; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL ASR

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Discomfort (2330); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr litigation records received.Litigation record alleges severe pain and discomfort in plaintiff¿s hip.Doi: (b)(6) 2007, dor: (b)(6) 2019, left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.Added: a2 (age and dob), a3 corrected: a1, b5, e1 (hospital), h6 (health effect-clinical code, medical device problem code).

Event Description

Additional information received and stated the following: the patient was revised to address failed left tha, chronic hip pain, and elevated metal ions.Operative note reported extensive metalosis, and grossly loose acetabular component.Rim intact, large grade 2c defect in terms of rim, but extensive bone loss medially from 7 o'clock to 12 o'clock with exposed soft tissue.Extension posterior inferior and superiorly 3 and 4 cm.X-ray revealed osteolysis, malposition acetabular component.Debrided all nonviable tissue and infected synovium.There was extensive metalosis and corrosion.Medial aspect of the quadralateral plate was missing and augmented with 2 zimmer tm disk augments with the goal to re-establish a medial wall.After a review of the medical records, the orthopaedics clinic note particularly the imaging results, plain films of the left hip show that he has intact left total hip replacement without any evidence of loosening, however, there is some heterotropic ossification formation.There were some metal debris in his leg from the gunshot wound and not from any sort of bead shedding due to the fact that they were present in prior films.

• Brand Name: UNK HIP FEMORAL HEAD METAL ASR
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11716353
• MDR Text Key: 247001500
• Report Number: 1818910-2021-08585
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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 ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male