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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

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

The literature article entitled, "comparison of ceramic-on-ceramic bearing vs ceramic-on-highly cross-linked polyethylene-bearing surfaces in total hip arthroplasty for avascular necrosis of femoral head: a prospective cohort study with a mid-term follow-up" written by bin feng, yi ren, shilang cao, jin lin, jin lin, wenwei qian, and xisheng weng published by journal of orthopaedic surgery and research 2019 was reviewed.The article's purpose was to evaluate the clinical outcomes, health-related quality of life, and wear of the bearing surface between ceramic on ceramic (coc) and ceramic on highly cross linked polyethylene (coxpe) tha for patients of avn after midterm follow-up.Data was compiled from 99coc and 77 coxpe thas.Findings were both groups showed significant improvements in hhs scores with no difference between two bearing surfaces, no radiographic detection of osteolysis and loosening.All implants were depuy.Figure 1 provides close up radiographic images of the femoral head within acetabular cup.Depuy products: pinnacle cup, poly liner, ceramic liner, ceramic head, corail uncemented stem.Adverse events: dislocations in both groups (treated by closed reduction).Post op periprosthetic distal femoral fracture (treated by open reduction and internal fixation).Reports of noise (grinding noise, snap noise) in coc group (no treatments).Infection (treated by debridement).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary =no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h6 clinical code: appropriate term/code not available (e2402) is used to capture infections.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10926906
• MDR Text Key: 218942593
• Report Number: 1818910-2020-25750
• 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,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention