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

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of or Failure to Bond (1068); Failure to Osseointegrate (1863)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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, ¿the corail stem as a reverse hybrid ¿ survivorship and x-ray analysis at 10 years¿ by helge wangen, et al, published by hip international (2017), doi: 10.5301/hipint.5000477, was reviewed.The authors report their experience of reverse hybrid tha, using the elite plus polyethylene cemented cup together with the corail fully hydroxyapatite-coated uncemented stem and a 28-mm alumina ceramic head implanted between january 2000 to december 2003.Implanted products: corail stem, charnley elite plus cup cemented with competitor cement, and a 28-mm alumina ceramic head by ceramtech.Results: 1 two-stage revision for early postoperative infection.2 early infections treated with surgical debridement.2 infections treated with debridement and cup revision.1 heterotopic ossification treated with excision of the heterotopic bone and component retention.1 periprosthetic fracture treated with stem revision.1 cup scheduled for revision due to aseptic loosening.There is insufficient information within the text of the article to attribute the loosening to the cup that cemented with competitor cement.1 cup loosening due to infection not revised because of patient refusal.1 stem mispositioned into varus due to undersized stem.2 stems identified as too small- not revised.There were noted cases of acetabular and femoral radiolucent lines that required no intervention and were not progressive.Captured in this complaint: elite plus cup- implant loosening due to infection; femoral head- no reported product problem; corail stem- mispositioned and implant fit: too small.Patient harms: infection, extraskeletal ossification, fracture post-op, surgical intervention, and medical device removal.".

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9376037
• MDR Text Key: 184382420
• Report Number: 1818910-2019-117982
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1