MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN BONE SCREW; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Malposition of Device (2616)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 03/22/2008

Event Type  Injury  

Manufacturer Narrative

An event regarding malposition and instability involving an unknown screw was reported.The event was confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿there is no examination of the explanted components from the december 1, 2015, no mri or histopathology results consistent with altr, no description of corrosion, no dated serial x-rays or mri images available for review, and no examination of the explanted revision components.There is no evidence that the voluntary recall of the acetabular component was associated with an increased rate of component loosening.One millimeter of lucency five months post-operative without migration does not confirm pathology.Subsequent instability and pain were due to surgical technique regarding cup positioning, soft tissue tension and misplaced acetabular screw.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.¿ product history review: not performed as the device was not identified.Complaint history review: not performed as the device was not identified.Conclusions: the reported event of instability and malposition shell was confirmed.Based on the clinician¿s review, ¿subsequent instability and pain were due to surgical technique regarding cup positioning, soft tissue tension and misplaced acetabular screw.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.¿.

Event Description

Update as per investigation- 'subsequent instability and pain were due to surgical technique regarding cup positioning, soft tissue tension and misplaced acetabular screw.'.

• Brand Name: UNKNOWN BONE SCREW
• Type of Device: HIP IMPLANT
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7694056
• MDR Text Key: 114177745
• Report Number: 0002249697-2018-02192
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 90