MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#5L; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 6265-5205

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Necrosis (1971); Injury (2348)

Event Date 02/28/2012

Event Type  Injury  

Manufacturer Narrative

An event regarding an intraop calcar fracture involving a citation stem was reported.The event was confirmed.Method & results: product evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: review of medical records by a consulting clinician indicated: "on (b)(6) 2012 a primary left total hip arthroplasty was performed for a diagnosis of avascular necrosis of the left femoral head.A dall-miles cable and sleeve was placed around the neck for a crack in the calcar during the surgery.Otherwise, uncomplicated surgery was described and the patient was discharged home on (b)(6) 2012.An office visit of (b)(6) 2012 notes, ''hip feels great.X-ray:excellent position." product history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there is 1 other event for the lot referenced, however, it is for the same patient.Conclusion: an event regarding an intraop calcar fracture involving a citation stem was reported.Review of medical records by a consulting clinician confirmed the event, however the root cause could not be determined: "on (b)(6) 2012 a primary left total hip arthroplasty was performed for a diagnosis of avascular necrosis of the left femoral head.A dall-miles cable and sleeve was placed around the neck for a crack in the calcar during the surgery.Otherwise, uncomplicated surgery was described and the patient was discharged home on (b)(6) 2012.An office visit of (b)(6) 2012 notes, ''hip feels great.X-ray: excellent position." no further investigation for this event is possible at this time.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Per medical review: "on (b)(6) 2012 a primary left total hip arthroplasty was performed for a diagnosis of avascular necrosis of the left femoral head.A dall-miles cable and sleeve was placed around the neck for a crack in the calcar during the surgery." this pi to cover intraop calcar bone fracture.

• Brand Name: CITATION TMZF HA SHORT SIZE#5L
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7534318
• MDR Text Key: 108920998
• Report Number: 0002249697-2018-01518
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 6265-5205
• Device Lot Number: 37705301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2011
• 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: 70 YR
• Patient Weight: 77