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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Hematoma (1884); Inflammation (1932); Sepsis (2067); Joint Dislocation (2374)

Event Type  Injury  

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.

Event Description

The literature article entitled, "uncemented total hip arthroplasty in octogenarian and nonagenarian patients" written by giuseppe toro, hugo bothorel, mo saffarini, laurent jacquot, julien chouteau, and jean-charles rollier published european journal of orthopaedic surgery & traumatology published online 2 june 2018 was reviewed.The article's purpose was to compare functional outcomes and complication rates of uncemented tha in patients aged >80 to patients aged <80; and determine demographic and morphological factors that independently influence functional outcomes.Data was compiled from 411 thas in 387 patients (24 bilateral) between august 2012 and june 2015.All patients received the same depuy stem and were utilized in conjunction with one of three products: novae sunfit dual mobility, pinnacle hemispheric, or novae e th hemispheric with screws.Table 3 provides patient identifiers for patients who experienced intraoperative/post-operative periprosthetic femoral fractures/cracks.All cracks were treated with partial weight bearing and cerclage for intraoperative cracks.Table 2 provides a list of complications (categorized as generalized adverse events) but the article does not clarify if patients experienced more than one complication, therefore exact quantities cannot be determined.The article does not provide adequate information to determine accurate quantities of products involved in the generalized adverse events.Material of bearing surfaces not identified.This article reports these implants are uncemented.Figure 3 provides a radiographic image of a periprosthetic fracture repaired with cerclage.Depuy products: corail stem, pinnacle cup, liner (material unknown), head (material unknown) serf products: novae sunfit dual mobility, novae e th hemispheric with screws (also dual mobility), poly liner for either novae sunfit or novae e th cup.Generalized adverse events of data set: leg length discrepancy (treated by revision), radiolucency and aseptic loosening (treated by revision), stem migration (treated by revision), dislocation (treatment unknown/involved products unknown), cyst (clinically associated with inflammatory response, treated by revision), cracks and periprosthetic fractures (treated by revision and anatomic location not identified), hematoma (treatment not identified), distal femoral fracture (treatment not identified), pulmonary embolism (treatment not identified), sepsis (treated by revision), stroke (treatment not identified).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of a singular x-ray image does not depict any dislocation event.Nothing indicative of a product problem is identified.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 : a device history record (mre) review, was not possible because the required lot code was not provided.

• 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: 11047955
• MDR Text Key: 223456643
• Report Number: 1818910-2020-27357
• 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
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention