Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 6570-0-228
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2019
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
Primary right hip procedure.It was reported that after reducing the hip and irrigating the patient, a pink chip was noticed coming out of the patient.Patient was dislocated and a chip was confirmed to have come off the biolox ceramic head.While waiting for a replacement head from the branch, the surgeon decided to broach for a larger stem (there are no allegations against the stem).The newly implanted stem, head and adm/mdm insert were removed and implanted with a larger stem, another head of the same catalog number, and an adm/mdm insert of the same catalog number.The surgery was completed successfully with an approximately 10-15 minute delay overall.Rep provided an implant sheet and reported that no further information is available.
 
Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event of the crack/fracture was confirmed through material analysis of the returned product.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 17 june 2019 noted: the v40 head was returned engaged within the insert.Damage was observed on the distal rim of the ceramic head consistent with contact against a hard object.There was nothing noteworthy observed on the articulating surface of the insert.Metal transfer markings were observed on the distal surface of the v-40 head.A non- continuous metal transfer ring was observed on the female taper of the v-40 head.The observation of a continuous metal transfer ring at the proximal end of the head taper is consistent with proper seating between the head taper and stem trunnion.Macroscopic surface features on the proximal surface indicate that fracture occurred in overload initiating interiorly and propagating outward.A material analysis has been performed.The report concluded: the fracture morphology indicated that the v-40 head fractured in overload with the fracture origin occurring interiorly and propagating outward.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding crack/fracture of a ceramic head during surgery was reported.Visual inspection was performed as part of the material analysis report (mar), dated 17 june 2019 noted: the v40 head was returned engaged within the insert.Damage was observed on the distal rim of the ceramic head consistent with contact against a hard object.There was nothing noteworthy observed on the articulating surface of the insert.Metal transfer markings were observed on the distal surface of the v-40 head.A non-continuous metal transfer ring was observed on the female taper of the v-40 head.The observation of a continuous metal transfer ring at the proximal end of the head taper is consistent with proper seating between the head taper and stem trunnion.Macroscopic surface features on the proximal surface indicate that fracture occurred in overload initiating interiorly and propagating outward.A material analysis has been performed.The report concluded: the fracture morphology indicated that the v-40 head fractured in overload with the fracture origin occurring interiorly and propagating outward.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
Primary right hip procedure.It was reported that after reducing the hip and irrigating the patient, a pink chip was noticed coming out of the patient.Patient was dislocated and a chip was confirmed to have come off the biolox ceramic head.While waiting for a replacement head from the branch, the surgeon decided to broach for a larger stem (there are no allegations against the stem).The newly implanted stem, head and adm/mdm insert were removed and implanted with a larger stem, another head of the same catalog number, and an adm/mdm insert of the same catalog number.The surgery was completed successfully with an approximately 10-15 minute delay overall.Rep provided an implant sheet and reported that no further information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DELTA V-40 CERAMIC HEAD 28/+4
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8540528
MDR Text Key142783955
Report Number0002249697-2019-01683
Device Sequence Number1
Product Code JDI
UDI-Device Identifier04546540608529
UDI-Public04546540608529
Combination Product (y/n)N
PMA/PMN Number
K173499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Catalogue Number6570-0-228
Device Lot Number68735603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Initial Date Manufacturer Received 03/26/2019
Initial Date FDA Received04/23/2019
Supplement Dates Manufacturer Received07/01/2019
Supplement Dates FDA Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
-
-