MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON TIBIAL PROTECTION SHIM SIZE 3 PER FILE K2152; KNEE INSTRUMENT

Catalog Number I-K2152PP03

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Tibial baseplate cover broke a piece off the back when removing it from the base plate.This occured after cementing the base plate and femur during the rtk.

Manufacturer Narrative

An event regarding crack/fracture involving an triathlon tibial protector was reported.The event was confirmed.Method & results: device evaluation and results: material analysis has been performed on the received devices.Visual inspection shows that the tibial protector was fractured and damaged.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been 2 other event for the lot referenced.Conclusions: the event was confirmed.Visual inspection shows that the tibial protector was fractured and damaged due to overload condition.If the additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Tibial baseplate cover broke a piece off the back when removing it from the base plate.This occured after cementing the base plate and femur during the rtk.

• Brand Name: SPECIALTY TRIATHLON TIBIAL PROTECTION SHIM SIZE 3 PER FILE K2152
• Type of Device: KNEE INSTRUMENT
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5930111
• MDR Text Key: 54539688
• Report Number: 0002249697-2016-02860
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

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 Catalogue Number: I-K2152PP03
• Device Lot Number: ERDA05733A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR