MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

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

Patient Problem Death (1802)

Event Date 10/07/2013

Event Type  Death  

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

Literature article "imageless computer-assisted versus conventional total hip arthroplasty: one surgeon¿s initial experience" by matthew l.Brown, md,jeffrey d.Reed, bs, christopher j.Drinkwater, md published by the journal of arthroplasty dx.Doi.Org/10.1016/j.Arth.2013.10.007 on 7 october 2013 was reviewed for mdv reportability.The article purpose: "the present study seeks to compare conventional tha, and tha using an imageless cas system, with regards to radiographic measures of component positioning, operative efficiency and risk, complication rates, cost, and patient functional outcome at midterm follow-up.The article reports: "the senior author has performed tha using an image-free, non-ct based cas system (ci cas, depuy orthopaedics, warsaw, in, usa) running first generation software; as well as tha using conventional instrumentation." noted that pinnacle acetabular components and summit femoral components were implanted in cas series patients.Pinnacle cups and summit stems were predominately implanted in on-cas series patients as well a minority of asr cups and s-rom or trilock stems.It is noted that cups were outside of lewinnek's safe zone in cas group (19) and conventional group (11)."a consecutive series of 317 patients (341 hips) underwent tha performed by the senior author between february 2006 and march 2008; 119 patients (126 hips) underwent tha using the cas system, while 198 patients (215 hips) underwent tha using conventional instrumentation." complications in the cas series: nerve palsies (3), superficial infections (2), deep infection requiring explant (1), post-operative thromboembolic events (4), dislocation (1), post-operative periprosthetic fracture (1 - anatomical location not specified), death (1 - due to cardiac arrhythmia), ruptured diverticulum unrelated to pin placement (1), increased blood loss requiring transfusions (19).Complication in conventional series: calcar fractures requiring cabling (10 - timing of occurrent not specified), superficial infection (1), deep infection requiring explant (1), thromboembolic events (3), dislocation (1), and heterotopic ossification (2), increased blood loss requiring transfusions (26).The article does not specify which products were related to specific advents and it does not specify which products were implanted in the patient who died as a complication or when the death occurred.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number 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.Device history lot null.Device history batch null.Device history review null.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.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9008545
• MDR Text Key: 157796565
• Report Number: 1818910-2019-104069
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death