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 Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 11/22/2018

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.(b)(4).

Event Description

"literature article entitled, ¿is patient satisfaction related to patient reported sounds from ceramic on ceramic total hip arthroplasty? a study of 265 hips¿ by jonathan a.Barrow, et al, published by european journal of orthopaedic surgery and traumatology (2019), vol.29, pp.1243-1251, was reviewed.The purpose of this article was to determine the rate of noise generation from ceramic-on-ceramic hips and to determine if this has an influence on patient satisfaction.This retrospective study reviewed 246 uncemented thas implanted between september 2007 and august 2010.Implanted depuy products: 246 pinnacle cups, biolox ceramic liners and heads, and corail stems.Results: 42 reports of audible noise from the hip.There was no treatment or intervention required.1 infection treated with incision and debridement and device retention.1 neuropraxia.Treatment is unknown.The neuropraxia was fully resolved at 39 months.2 dislocations treated with closed reduction.Captured in this complaint: pinnacle cup and corail stem: no reported product problem.Biolox liner and head: implant noise and implant dislocation.Harms: surgical intervention and device repositioning.Symptoms: joint dislocation, infection, nerve injury.".

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial 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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9622520
• MDR Text Key: 185811638
• Report Number: 1818910-2020-02676
• Device Sequence Number: 1
• Product Code: KWZ
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention