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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/03/2015

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, "impingement-free range of movement, acetabular component cover and early clinical results comparing 'femur first' navigation and 'conventional' minimally invasive total hip arthroplasty" by t.Renkawitz, m.Weber, h-r.Springorum, e.Sendtner, m.Woerner, k.Ulm, t.Weber, and j.Grifka published by the bone & joint journal, doi: 10.1302/0301-620x.97b7.34729; on 3 february 2015 was reviewed for mdv reportability.The purpose: "we undertook a randomised controlled trial (rct) to assess whether the use of the ¿minimally invasive¿ femur-first navigation method would lead to a potential increased rom, sufficient acetabular component coverage and improved clinical outcomes compared with results obtained with conventional ¿minimally invasive¿ tha." the data included a total of 160 thas implanted with "press-fit acetabular components, uncemented hydroxyapatite-coated femoral components (pinnacle acetabular component, corail femoral component" between december 2011 and february 2013 with ages between 50 and 75 years.Table iii includes acetabular inclination ranges between 25.1 to 59.1 degrees and anteversion -4.1 to 40.8 degrees denoting mispositioned cups.Complications include: dislocation (1) received closed reduction & revision surgery, infection (1) with revision surgery (along with debridement, antiseptic lavage and change of liner/head), calcar fracture intraoperatively (1) treated with cerclage wire, partial sciatic nerve palsy that partially recovered within the following 12 months (1).Adverse events: surgical intervention, infection, femur fracture (intraoperatively), dislocation, nerve injury.Impacted products: depuy pinnacle liner, depuy pinnacle cup, unknown femoral head.

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.    corrected: h6 (device).Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 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 46581 0988
• MDR Report Key: 9008034
• MDR Text Key: 161965429
• Report Number: 1818910-2019-104049
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention