MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PCA MID STEM 5 RIGHT; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 6282-5-005

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

It was reported that surgeon revised patient's right hip due to stem breakage at the head neck junction.Surgeon revised stem and head, cup and liner were another company's devices.

Manufacturer Narrative

An event regarding an alleged crack/fracture involving a pca mid #5 stem was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as no device was returned.Medical records received and evaluation: medical records provided were reviewed by a clinical consultant who rejected the records because additional patient information, including operative and clinical records are required.Device history review: could not be performed as the lot number is unknown.Complaint history review: not performed as the lot number is unknown.Conclusions: medical records provided were reviewed by a clinical consultant who rejected the records because additional patient information, including operative and clinical records are required.The exact cause of the event could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that surgeon revised patient's right hip due to stem breakage at the head neck junction.Surgeon revised stem and head, cup and liner were another company's devices.

• Brand Name: PCA MID STEM 5 RIGHT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5275144
• MDR Text Key: 32962279
• Report Number: 0002249697-2015-04179
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831373
• 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,Followup
• Report Date: 11/13/2015

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 Catalogue Number: 6282-5-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention