MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 132 SIZE 4 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1601-04132

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an implant breach in a sterile seal.Contained seal on the outside but internal seal was broken, sterility compromised for a secure fitted advanced stem.It was noticed during a procedure, surgeon unaware.Was able to retrieve additional products for surgery.

Manufacturer Narrative

An event regarding a packaging issue involving a secur-fit stem.The event was confirmed.Method & results: -device evaluation and results: the box, inner and out blister labels and ifu were returned.The device was returned in the box with the plastic wrap.The plastic wrap was torn open near the top flap.A portion of the of the box on the back near the top is torn off.The tyvek sheet on both the outer and inner blister was not sealed.There is residue on both blisters where the tyvek would seal.-medical records received and evaluation: there is no indication patient factors contributed to the reported event.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the return of the device confirmed the event however the exact root cause could not be determined.Review of the device/packaging with the packaging operations team confirmed the outer and inner blisters were previously sealed.The residue on the seals of the blisters confirm the device was sealed.

Event Description

It was reported an implant breach in a sterile seal.Contained seal on the outside but internal seal was broken, sterility compromised for a secure fitted advanced stem.It was noticed during a procedure, surgeon unaware.Was able to retrieve additional products for surgery.

• Brand Name: 132 SIZE 4 SECUR-FIT ADVANCED STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6358509
• MDR Text Key: 68513937
• Report Number: 0002249697-2017-00667
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1601-04132
• Device Lot Number: MMERHK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2013
• 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): Other
• Patient Age: 93 YR