MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; IMPLANT

Catalog Number 502-03-54E

Device Problems Device Disinfection Or Sterilization Issue (2909); Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a left primary hip procedure, when the circulating nurse attempted to open the inner blister on the tritanium cup, the packaging was sticking to the foam insert of the cup and the nurse felt that the device partially lifted out of packaging and possibly touched her as a result.Another cup of same catalog and size was used and case was completed without any delay or adverse consequence to the patient.

Manufacturer Narrative

An event regarding a packaging issue involving a tritanium shell was reported.The event was confirmed.Method & results: device evaluation and results: the inner blister lid was stuck to the outer blister lid.It is noted that both blisters showed evidence of complete seal transfer.There is no indication that the sterility of the device was compromised.Medical records received and evaluation: not performed as the event is not related to patient factors.Device history review: review of the device history records indicates that all 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 inner blister lid was stuck to the outer blister lid.The root cause was determined to be a known packaging issue.Packaging innovations is aware of this, and has issued a memo.

Event Description

It was reported that during a left primary hip procedure, when the circulating nurse attempted to open the inner blister on the tritanium cup, the packaging was sticking to the foam insert of the cup and the nurse felt that the device partially lifted out of packaging and possibly touched her as a result.Another cup of same catalog and size was used and case was completed without any delay or adverse consequence to the patient.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• 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: 5080912
• MDR Text Key: 26249212
• Report Number: 0002249697-2015-03021
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 502-03-54E
• Device Lot Number: R75X8J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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: 72 YR