MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR; HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL SLEEVE ASR

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Test Result (2695); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/06/2019

Event Type  Injury  

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.

Event Description

Patient was revised to address elevated metal ion level.Doi: unknown; dor: (b)(6) 2019; unknown affected side.

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

Event Description

After review of medical records patient was revised to addressed painful right total hip arthroplasty.After splitting the gluteus maximus there was significant amount of metallosis along the posterior aspect of the hip which had infiltrated the region of the trochanteric bursa.A large bursal sac posterior and lateral to the hip which was excised and there was cloudy fluid resting within.Posterior pseudocapsule infiltrated with metallosis and necrotic tissue.The large metal head was removed and noted mild degree of corrosion at the trunnion.Acetabular component was removed with minimal bone loss and also within the pubis.Femoral component is well fixed in approximately 25 to 35 degrees of anteversion.Doi: (b)(6) 2009 dor: (b)(6) 2019 right 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 previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: h6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increased and bone injury.E3 initial reporter occupation: lawyer.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.

Event Description

Litigation records received.Records allege osteolysis, loss of mobility, adverse reaction to metal wear debris, emotional distress, and economic loss.

• Brand Name: UNK HIP FEMORAL SLEEVE ASR
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9525701
• MDR Text Key: 174943545
• Report Number: 1818910-2019-124763
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/06/2019

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 SLEEVE ASR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/22/2020; 07/05/2021; 09/15/2021
• Supplement Dates FDA Received: 01/24/2020; 07/14/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR UNI FEMORAL IMPL SIZE 43.; S2 HIGH OFFSET STEM.; UNK HIP ACETABULAR CUP ASR.
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR