MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH P4 28MM 10DEG INSERT OSTEOLOCK; IMPLANT

Catalog Number 5260-4-415

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 06/25/2014

Event Type  Injury  

Event Description

It was reported patient had a hip revision due to poly wear being worn out.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown liner.An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information (including x-rays and medical records) has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

A review of the device history records could not be performed because the device associated with this event was not returned nor was a valid lot code provided.A review of the complaint databases could not be performed because the device associated with this event was not returned nor was a valid lot code provided.Visual, dimensional and functional analysis could not be performed as the device was not returned.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported patient had a hip revision due to poly wear being worn out.

• Brand Name: P4 28MM 10DEG INSERT OSTEOLOCK
• Type of Device: 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3948941
• MDR Text Key: 4646070
• Report Number: 0002249697-2014-02811
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5260-4-415
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• 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): Required Intervention
• Patient Age: 69 YR