MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; IMPLANT

Catalog Number 5532-G-511

Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Implant was opened on to the field assuming/thinking it was a 5 by 11 ps bearing, (as package read) inside was a ts 19mm bearing.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding a product mix involving a triathlon ps insert was reported.The event was confirmed.-device evaluation and results: the device and packaging was received and the event was confirmed.-medical records received and evaluation: not performed as no medical intervention nor adverse consequences reported with event.-device history review: all units were accepted into final stock.-complaint history review: there has been (b)(4) other event reported for the referenced lot.Conclusions: the investigation determined the product mix occurred due to a router swap.Nc was raised to investigate and address the confirmed product mix and router swap.

Event Description

Implant was opened on to the field assuming/thinking it was a 5 by 11 ps bearing, (as package read) inside was a ts 19mm bearing.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 4848433
• MDR Text Key: 5874025
• Report Number: 0002249697-2015-01953
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5532-G-511
• Device Lot Number: LD8D7Y
• Other Device ID Number: STERILE LOT# MSGPH30A6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2249697-6/10/2015-007R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR