MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 09/03/2014

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

"literature article entitled, ¿the inflammatory phenotype in failed metal-on-metal hip arthroplasty correlates with blood metal concentrations¿ by erja-leena paukkeri, et al, published by plos one (2016), vol.11, no.5, 13 pages, doi:10.1371/journal.Pone.015512, was reviewed.In the present study, the authors aimed to have another approach to investigate and understand the cell types and mechanisms involved in armd by utilizing flow cytometry to further characterize the tissue reaction in failed mom implants using tissue obtained from asr revisions as an example.Implanted products: there were 4 asr resurfacing systems and 12 asr-xl systems studied in this article.Results: each of the 16 implants studied was revised.The revisions were divided into 1) revised due to pseudotumor, 2) revised due to elevated blood metal ions, and 3) revised due to unspecified ¿symptoms¿ that included pain, joint instability, and/or decreased joint range of motion.Every patient in the study had intraoperative confirmation of pseudotumor, soft tissue necrosis, and armd.The authors confirm that each patient had histologically confirmed elevated inflammatory markers, but there were no cases of infection identified.This complaint captures 16 total patients labeled cases 1-case 16 on the attached guidance sheet.Each case identifies the specific implant and associated events.Please link all related pcs to this parent (b)(4)." (b)(6) yo male with asr-xl implant.Revised 39 months after index hra due to due to elevated blood metal ions- co.10.5 ppb and cr.3.3 ppb, pseudotumor, and "symptoms" including pain, joint instability, decreased joint range of motion, and/or joint noise.Pseudotumor, armd, and soft tissue necrosis confirmed intraoperatively.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 patient code: not applicable (3189) used to capture medical device removal.Additional patient code: necrosis.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.Previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore no dhr (device history record) review for this individual asr component will be carried out at this point in time.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.The investigation to determine root cause was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9274566
• MDR Text Key: 184838114
• Report Number: 1818910-2019-112542
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR