MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM; IMPLANT

Catalog Number 2051-2048

Device Problems Material Integrity Problem (2978); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 10/03/2014

Event Type  Injury  

Event Description

Patients acetabulum was revised for poly wear.Cup was explanted and replaced with tritanium primary shell and mdm liner.

Manufacturer Narrative

Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Patient kept.

Manufacturer Narrative

An event regarding wear involving an omnifit liner was reported.Conclusion: no allegation of failure was made against the device.Based on the information provided there is no indication that the product reported in this investigation contributed to the event.

Event Description

Patients acetabulum was revised for poly wear.Cup was explanted and replaced with tritanium primary shell and mdm liner.

• Brand Name: SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4210959
• MDR Text Key: 22151691
• Report Number: 0002249697-2014-04052
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942900
• 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: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2000
• Device Catalogue Number: 2051-2048
• Device Lot Number: 18375904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/1995
• 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