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

Catalog Number 2051-2052

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the liner ring loosened and broke.Visible on xray.

Manufacturer Narrative

An event regarding crack/fracture involving an omnifit liner was reported.Conclusion: the event was reported for a fractured liner, no allegation of failure was made against the shell.Based on the provided information, the product reported in this investigation did not contribute to the event.No further investigation is required at this time.If additional information and/or device becomes available this record will be reopened.

Event Description

It was reported that the liner ring loosened and broke.Visible on xray.

• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5000274
• MDR Text Key: 22854099
• Report Number: 0002249697-2015-02624
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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