• 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 UNKNOWN TRITANIUM ACETABULAR CUP 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 UNKNOWN TRITANIUM ACETABULAR CUP PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_JR
Device Problem Osseointegration Problem
Event Date 02/19/2018
Event Type  Injury  
Manufacturer Narrative

An event regarding loosening involving a tritanium shell was reported. The event was not confirmed. Method & results: product evaluation and results: visual, dimensional, functional and material analysis not be performed as the device is not returned. Clinician review: no medical records were received for review with a clinical consultant. Product history review: a review of the device history records could not be performed as lot information was not provided. Complaint history review: a complaint history review could not be performed as lot code information was unknown.   conclusions: it was reported that patient was revised due to loosening. The event could not be confirmed nor the exact cause of the event could be determined because insufficient information was available. No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened. Device not returned.

 
Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with a tritanium acetabular cup in her right hip on (b)(6) 2016 and a period of time after the implantation began experiencing discomfort. It is alleged in light of worsening symptoms she was taken for revision surgery on (b)(6) 2018 and "during the revision surgery, it was discovered that the acetabular cup was loose with gross motion and with only a fibrous bond. There was some metallosis around the screws, which was curetted out. There was fluid over the anterior aspect of the hip. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN TRITANIUM ACETABULAR CUP
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
collin neitzel
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key9794601
Report Number0002249697-2020-00463
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/05/2020 Patient Sequence Number: 1
-
-