MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/01/2018

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.(b)(4).

Event Description

Literature article entitled, ¿use of beta-blockers and risk of aseptic loosening in total hip and knee arthroplasty: a nested case ¿ control study¿ by pablo carnero- martín de soto, et al, published by journal of musculoskeletal and neuronal interactions (2019), vol.19, no.1, pp.104-111, was reviewed.The purpose of this article was to examine the effect of beta-blockers on the risk of aseptic loosening after total hip and total knee arthroplasty revisions due to aseptic loosening.The tha devices were manufactured by depuy and the tka devices were competitor products.Inclusion criteria for the study was revision due to aseptic loosening of the cup or stem.Depuy implants: 14 pinnacle cups paired with corail stems.The femoral heads and acetabular liners are assumed to be depuy products.Results: 14 revisions for aseptic loosening due to loosening of the cup and/or the stem.Captured in this complaint: 14 cups and 14 stems: implant loosening at the bone to implant interface.Patient harms: device revision or replacement and inadequate osseointegration.Femoral head and acetabular liner: no reported product problem.Patient harms: device revision or replacement and no information available.There were no allegations of product deficiencies of nor any indication that the femoral heads or acetabular liners contributed to the reasons for the revision surgeries.

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9972574
• MDR Text Key: 188366820
• Report Number: 1818910-2020-10909
• Device Sequence Number: 1
• Product Code: KXA
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention