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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); 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.(b)(4).

Event Description

The literature article entitled, "pattern of osteolysis around two different cementless metal-backed cups" written by alexandra m.Claus, md, phd, christi j.Sychterz, ms, robert h.Hopper, jr, phd, and charles a.Engh, md published by the journal of arthroplasty vol.16 no.8 suppl.1 2001 was reviewed.The article's purpose was to evaluate "whether holes in the acetabular shell affect the radiographic pattern of osteolysis in thas." data was compiled from two groups of thas.First group had 126 thas (121 patients of 58 men and 63 women) receiving implants between october 1982 to august 194 using aml cup with trip spike without holes, poly liner and nonmodular aml cocr stems.The second group of 112 thas (107 patients of 67 men and 40 women) receiving implants between february 1985 to march 1989 with arhropor cups with holes locking screws and poly liners with modular aml stems utilizing either cocr heads or ceramic heads.The articles does not mention debris.Adverse events for aml cups: 5 cup revisions for liner wear and osteolysis, loose, migration, mispositioned.Adverse events for arthropor cups: 5 cup revisions for liner wear and osteolysis, loose cups.

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.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 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: 9459293
• MDR Text Key: 185123298
• Report Number: 1818910-2019-122779
• Device Sequence Number: 1
• Product Code: LPH
• 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: 11/20/2019

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: 11/20/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention