• 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 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

  • 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 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 502-03-56E
Device Problems Failure to Osseointegrate; Osseointegration Problem
Event Date 01/02/2018
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Review of the device history records indicate that devices were manufactured and accepted on into final stock with no reported discrepancies. There have been no other events for the lot referenced.

 
Event Description

It was reported that patient's right hip was revised. Cause not explicitly reported but a video sent by the rep has the following surgeon reports: "i just shelled the cup out, and can see the marks in the bone corresponding to the ridges on the tritanium. Absolutely no bony ingrowth; there's no bone loss at all, the only thing holding this cup was that one screw that i put in. ".

 
Manufacturer Narrative

An event regarding loosening involving a titanium acetabular shell was reported. The event was confirmed by medical review. Method & results: product evaluation and results: the device was not returned, however, an image of the explanted acetabular shell was attached. It showed blood and biological material adhered to the porous structure of the shell. Clinician review: a review of the provided medical reviews and x-rays by a clinical consultant indicated: ¿no clinical or past medical history, no patient demographics, no revision operative report, and no examination of the explanted components are available. X-rays labeled ¿two weeks¿¿ and ¿three months¿ post-op¿ suggest incomplete medialization and bony contact of the acetabulum, possibly due to under remaining of 2-millimeters in this male patient with good quality bone. There is no history given of medications, disease states, or other clinical factors that could discourage biologic fixation in this case. There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation. ¿ product history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the event of loosening of the acetabular shell was confirmed by the clinician. Based on the clinician¿s review, ¿x-rays labeled ¿two weeks¿¿ and ¿three months¿ post-op¿ suggest incomplete medialization and bony contact of the acetabulum, possibly due to under remaining of 2-millimeters in this male patient with good quality bone. ¿ the exact root cause could not be determined based on missing medical documentation to make further assessment. If further medical information is received the complaint will be reopened and reassessed.

 
Event Description

It was reported that patient's right hip was revised. Cause not explicitly reported but a video sent by the rep has the following surgeon reports: "i just shelled the cup out, and can see the marks in the bone corresponding to the ridges on the titanium. Absolutely no bony ingrowth; there's no bone loss at all, the only thing holding this cup was that one screw that i put in. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
brian lauro
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key7220072
Report Number0002249697-2018-00246
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number502-03-56E
Device LOT NumberT3767W
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/25/2018 Patient Sequence Number: 1
-
-