MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#7R; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 6265-5217

Device Problems Break (1069); Corroded (1131); Fracture (1260)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not available.

Event Description

It was reported through the filing of a lawsuit that allegedly in (b)(6) 2017 he experienced sudden acute right hip pain as he was getting out of his car.He was seen in the emergency room where x-rays revealed the femoral neck of his implant was fractured which was the cause of his pain.It is further alleged that he was revised on or about (b)(6) 2017 and during the procedure an extensive amount of black tissue reflecting corrosion was found and the femoral neck itself had been eroded.

Event Description

It was reported through the filing of a lawsuit that allegedly in february 2017 he experienced sudden acute right hip pain as he was getting out of his car.He was seen in the emergency room where x-rays revealed the femoral neck of his implant was fractured which was the cause of his pain.It is further alleged that he was revised on or about *(b)(6), 2017 and during the procedure an extensive amount of black tissue reflecting corrosion was found and the femoral neck itself had been eroded.

Manufacturer Narrative

Additional information: device information an event regarding crack/fracture involving an unknown citation stem was reported.The event was not confirmed.Method & results: -product evaluation and results: a visual, functional and dimensional inspection could not be performed as the product was not returned.-clinician review: no medical records or x-rays were made available for evaluation.-product history review: not performed as the device was not properly identified.-complaint history review: not performed as the device was not properly identified.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: CITATION TMZF HA SHORT SIZE#7R
• 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
• MDR Report Key: 7480456
• MDR Text Key: 107144667
• Report Number: 0002249697-2018-01319
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K053528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2011
• Device Catalogue Number: 6265-5217
• Device Lot Number: 19074301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention