MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #4 PS INSERT 13MM; IMPLANT

Catalog Number 5532P413

Device Problems Device Expiration Issue (1216); Use of Device Problem (1670)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

The customer reported that an out of date triathlon device was implanted into a patient during a primary total knee replacement.The date of expiry of the implant was in (b)(6) 2015 according to the sticker provided.The sales representative further reported that an audit was undertaken in the hospital 1-2 months ago and short dated stock was flagged to the customer at that time.Since the audit the customer has not requested that short dated stock be replaced.The consultant was reported to have held a team brief prior to the case and checked with staff whether all required devices were available for the case and staff allegedly confirmed that they were.On the day of the case it was discovered that this particular implant had expired and the customer checked immediately with the rep whether the device could be implanted and the rep advised against it.The customer asked whether the rep was able to get another device from a nearby hospital.When the rep was less than 15 minutes from theatres with the replacement device, it was confirmed that the surgeon had already taken a decision to implant the out of date device.There was an estimated delay of approximately 30-35 minutes while attempts were made to locate an alternative device that was within date.The patient has been informed.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

An event regarding implantation of a triathlon insert that has passed its expiry date was reported.Based on the provided information, the insert component was implanted after its shelf life was expired.The expiry date was may-2015 and the product was implanted on (b)(6) 2015.Implanting a device that has passed its expiry date is an off-label application.It is reported that there was a 30-35 minutes delay in surgery.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The customer reported that an out of date triathlon device was implanted into a patient during a primary total knee replacement.The date of expiry of the implant was in may 2015 according to the sticker provided.The sales representative further reported that an audit was undertaken in the hospital 1-2 months ago and short dated stock was flagged to the customer at that time.Since the audit the customer has not requested that short dated stock be replaced.The consultant was reported to have held a team brief prior to the case and checked with staff whether all required devices were available for the case and staff allegedly confirmed that they were.On the day of the case it was discovered that this particular implant had expired and the customer checked immediately with the rep whether the device could be implanted and the rep advised against it.The customer asked whether the rep was able to get another device from a nearby hospital.When the rep was less than 15 minutes from theatres with the replacement device, it was confirmed that the surgeon had already taken a decision to implant the out of date device.There was an estimated delay of approximately 30-35 minutes while attempts were made to locate an alternative device that was within date.The patient has been informed.

• Brand Name: TRIATHLON #4 PS INSERT 13MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4884236
• MDR Text Key: 6018064
• Report Number: 0002249697-2015-02172
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 5532P413
• Device Lot Number: LBX587
• Other Device ID Number: STERILE LOT: L6150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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
• Patient Age: 77 YR