MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 04/10/2018

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.(b)(4).

Event Description

The literature article entitled, "primary total hip arthroplasty for charcot arthropathy is associated with high complications but improved clinical outcomes" written by brian p.Chalmers, md, meagan e.Tibbo, md, robert t.Trousdale, md, david g.Lewallen, md, daniel j.Berry, md, and matthew p.Abdel, md published by the journal of arthroplasty made available online 10 april 2018 was reviewed.The article's purpose: "the goal of this study was to analyze the outcomes of tha for end-stage charcot arthropathy at a single institution with specific focus on (1) survivorship free of revision or reoperation, (2) complications, (3) clinical outcomes, and (4) radiographic outcomes." data was compiled from 11 patients and 12 thas (age range 31-79 years receiving implantations between january 1, 2007 and december 31, 2014.It is noted depuy products were utilized in conjunction with non-depuy products with only 1 acetabular component identified as depuy (pinnacle) and depuy femoral components consisted of 5 aml stems, 2 summit stems and 1 srom stem leaving the 4 remaining as non-depuy stems.Bearing surface materials are unknown.The article reports all acetabular components were uncemented and fixated with 2 screws and all but 1 non-depuy stem were uncemented.The article provides a table (table 1) with patient identifiers but fails to assign products to each patient and therefore specific adverse events cannot be associated with specific products.The article provides radiographic imaging for pre-operative conditions without implantations for figures 2-4 and provides radiographic imaging of unidentified hip implant in figure 1b and 1c with preoperative image in figure 1a of the 45 year old male patient.The figure note gives no indication of any adverse events and describes the following in the figure 1 note: "he underwent a tha with a tantalum acetabular cup, a tantalum augment, and supplemental screw fixation for a paprosky type 3a acetabular bone defect and a fully coated femoral stem as noted in the ap hip (b) and cross-table lateral (c) radiographs." depuy products: pinnacle cup, summit stem, aml stem, srom stem, unknown femoral head, unknown liner narrative description adverse events without identified products: dislocations (treated by closed reduction and/or revision) superficial wound infected (treated by antibiotics) intraoperative femoral fracture (treated by cerclage cable).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9813735
• MDR Text Key: 188472251
• Report Number: 1818910-2020-07391
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention