MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW CR TIBIAL INSERT TRIAL #3 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-309A

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 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dr (b)(6).Hit the trial with a mallet and the poly trial broke.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection evaluates that the triathlon insert trial was fractured into two pieces.Medical records received and evaluation: there is no indication that patient factors contributed to the reported event.Device history review: review of the device history records indicates 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: visual inspection confirmed the reported event.Triathlon trial was fractured into two pieces.An nc was raised due to an exceeded complaint rate for crack/fracture/wear/damage for triathlon modified insert trials, catalogs: 5530-t-xxxa and 5532-t-xxxa.This event is in the scope of the (b)(6).No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened and re-evaluated.

Event Description

Dr.(b)(6) hit the trial with a mallet and the poly trial broke.

Manufacturer Narrative

Additional information: date of birth; weight, weight units.

Event Description

Dr (b)(6) hit the trial with a mallet and the poly trial broke.

• Brand Name: MODIFIED HOLLOW CR TIBIAL INSERT TRIAL #3 - 9MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5784925
• MDR Text Key: 49292454
• Report Number: 0002249697-2016-02217
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5530-T-309A
• Device Lot Number: PPMAP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2015
• 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: 78 YR
• Patient Weight: 54