MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; IMPLANT

Catalog Number 509-02-62G

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567); Expiration Date Error (2528); Environmental Compatibility Problem (2929)

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

Event Date 09/12/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the customer to the sales rep that locally, a member of staff has been checking expiry dates on products and marking them with a post it note when they are nearing the end of their shelf life.However, on this occasion, this item was marked to expire 11-2015 by staff when it actually expired 01-2015.The actual expiry date does not appear to have been confirmed prior to surgery and the expired product was implanted.This was then discovered when stickers were added to the sticker sheet.The device was immediately explanted and replaced.After implantation but prior to the end of the procedure.The patient was male, age not disclosed.The patient has not experienced any known adverse consequences.

Manufacturer Narrative

An event regarding an expired tritanium shell that was implanted.The event was confirmed.Method & results: -device evaluation and results: the returned product and manufacturing records were reviewed and both displayed the appropriate expiration date.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: review of the device history records indicates that all devices were manufactured within specification and accepted into final stock.-complaint history review: there have been no other events for this lot or sterile lot.Conclusions: the investigation concluded that implantation of the expired product was caused by user error.The customer reported that a member of staff had been checking expiration dates on products and marking the products with post it notes when they are nearing the end of their shelf life.This practice of using bright colored manually created expiration date identification stickers potentially contributed to the misreading of the handwritten date format.

Event Description

It was reported by the customer to the sales rep that locally, a member of staff has been checking expiry dates on products and marking them with a post it note when they are nearing the end of their shelf life.However, on this occasion, this item was marked to expire 11-2015 by staff when it actually expired 01-2015.The actual expiry date does not appear to have been confirmed prior to surgery and the expired product was implanted.This was then discovered when stickers were added to the sticker sheet.The device was immediately explanted and replaced.After implantation but prior to the end of the procedure.The patient was male, age not disclosed.The patient has not experienced any known adverse consequences.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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: 5141616
• MDR Text Key: 28258933
• Report Number: 0002249697-2015-03313
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: 509-02-62G
• Device Lot Number: MHRA4K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2010
• 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