MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 06/24/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Polyethylene liner dissociation is a complication of the depuy pinnacle cup: a report of 23 cases" by andrew yun md, emmanuel n.Koli md, john moreland md, richard iorio md, john f.Tilzey md, j.Wesley mesko md, gwo-chin lee md and mark froimson md published online 24 june 2015 by clinical orthopaedics and related research; doi: 10.1007/s11999-015-4396-5.(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 entitled "polyethylene liner dissociation is a complication of the depuy pinnacle cup: a report of 23 cases" by andrew yun md, emmanuel n.Koli md, john moreland md, richard iorio md, john f.Tilzey md, j.Wesley mesko md, gwo-chin lee md and mark froimson md published online 24 june 2015 by clinical orthopaedics and related research; doi: 10.1007/s11999-015-4396-5 was reviewed for mdr reportability.The article entails 23 cases of depuy pinnacle acetabular component with a polyethylene liner failures.All 23 cases reported a new and sudden onset of discomfort with audible, reproducible squeaking.Intra-operative findings were well-fixed acetabular components and femoral implants but the liner was found to have displaced and rotated away from original position leaving the femoral head in direct contact with inner metal shell of the acetabular cup.Gross inspection reveals fracture of the three antirotation locking tabs at the periphery of the polyethylene rim.It is noted that documented measurements of cup implantation exceed outside of depuy's acceptable ranges for certain cases.Case 16 is a (b)(6) yo male who received revision 80 months post initial implantation.Cup abduction 40 degrees and anteversion 41 degrees.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number 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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8908800
• MDR Text Key: 155064166
• Report Number: 1818910-2019-101574
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR