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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Osteolysis (2377); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)

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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, ¿revisions of metal-on-metal hip resurfacing: lessons learned and improved outcome¿ by koen a.Se smet, md, published by orthopedic clinics north america (2011), no.42, pp.259-269, was reviewed.The aim of this retrospective, consecutive case series of a single surgeon was to assess the outcome following revision of mom hemiarthroplasties.In addition, the authors assessed whether the lessons learned from the initial previously reported experience improved outcome, and whether screening with the use of metal ions had an effect on post-revision outcome.This complaint captures the revised depuy mom components.The products used at revision are unknown.Implanted products: 10 asr hemiarthroplasties (cup and head) and 2 asr xl thas (cup, head, augment).The remainder of the 113 hips studied were from competitor products.Results: the results of this study were not separated by product and/or manufacturer.This complaint will capture all reported reasons for revision surgery and intraoperative findings.57 cup malpositioning.15 cup loosening.11 head misposition.21 head loosening.57 osteolysis (acetabular and femoral).6 periprosthetic femur fractures.6 infections.40 elevated blood heavy metal.Mean co 22.42 ppb and mean cr 22.39 ppb.Intraoperative findings: osteolysis, unspecified impingement, oversized components (unspecified components and locations), metallosis, metal debris, hypersensitivity (pseudotumor), and soft tissue fluid collections, and ground swelling.There were six instances of femoral component loosening attributed to pseudotumor formation.The authors found significant wear on the bearing surfaces intraoperatively.Only 4 patients requiring surgery reported no pain.This complaint captures all adverse events and intraoperative findings listed within the article.The authors do not specify which product or manufacturer is associated with each event.Included within this complaint: 1 asr hemiarthroplasty (head and cup) and 1 ars-xl (head, cup, augment).The implants used in the revision surgery were competitor products and are therefore not captured within this complaint.The authors provide radiographic evidence and patient identifiers for one patient having an asr hemiarthroplasty revised.This information is captured on the attached guidance document and should be linked to parent (b)(4)." this pc contains one additional pc to capture a single case study within the article labeled 49 yo female.Please link the additional pc to the parent (b)(4).This complaint is for the asr hemiarthroplasty.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Corrective action was not indicated.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Post market surveillance is per sep 419.Additional information: h6 patient code: (3189) used to capture the medical device removal.

• 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: 9250404
• MDR Text Key: 177705611
• Report Number: 1818910-2019-112834
• Device Sequence Number: 1
• Product Code: KXA
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• 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: 10/07/2019
• 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