MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM; IMPLANT

Catalog Number 2051-2052

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 09/18/2013

Event Type  Injury  

Event Description

It was reported that there was a removal of a series 2 insert due to wear of the insert.The surgeon also removed head.

Manufacturer Narrative

The provided medical records and radiology images reviewed by a clinical consultant indicated that in addition to the reported liner wear, the shell appeared loose.The loosening was likely caused by osteolysis.The clinical consultant indicated that ¿the osteolysis should be considered secondary to the poly wear as it is universally known that polyethylene wear particles are osteolytic under the conditions prevailing in the arthroplasty joint.¿ it was also noted by the clinical consultant that no other procedure-related issues are present.Component position is adequate for both stem and cup.As such the root cause of this event is an adverse mix of patient-related and procedure-related factors and is not device-related.No device history review or complaint review was performed as the device was not properly identified.Not returned.

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4017516
• MDR Text Key: 4846597
• Report Number: 0002249697-2014-03131
• Device Sequence Number: 1
• Product Code: JDK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965056
• 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
• Report Date: 09/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2051-2052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2014
• 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: 51 YR