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

Catalog Number UNK HIP ACETABULAR CUP

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/01/2018

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.

Event Description

Literature article abstract entitled, ¿pigmented villonodular synovitis does not influence the outcome following cementless total hip arthroplasty using ceramic-on-ceramic articulation: a case control study with middle-term follow-up¿ by chi xu.Et al, published by journal of orthopaedic surgery and research (2018), vol.13, no.294, 8 pages, was reviewed.The purpose of this study was to investigate the disease recurrence rate and the treatment outcomes including harris hip scores, complications, and revision rates following cementless tha with coc articulation in patients with pvns (pigmented villonodular synovitis) in 22 patient between 200 and 2013.The authors paired competitor cup and stems with pinnacle cups and corail stems, and the coc articulation surface manufacturers were not specified.This complaint will capture the one patient result with a depuy stem and two results from an unknown cup and stem from the control group.The actual number of depuy products associated with the events in the control group are unknown.The head and liner results are not captured in this complaint as there is insufficient information to determine the manufacturer of the articulation surfaces.There is one radiographic image of a stable, unknown tha on page 5, fig.3.Results: 1 cup and stem revision for aseptic loosening and 1 cup and stem revision for infection were reported in the control group.No additional information is available for the control group.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images could not confirm the reported complaint.A root cause could not be determined.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 10955877
• MDR Text Key: 220002335
• Report Number: 1818910-2020-26215
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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: 11/18/2020
• Initial Date FDA Received: 12/06/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention