MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW CR TIBIAL INSERT TRIAL #4 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-411A

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During wound closure of a total triathlon knee replacement, the surgeon showed me tiny flecks of green in the patient's tissue that were the same colour as the size 4 trial tibial insert, and that he attributed to breaking off the trial insert during trialling of the final sizes.

Manufacturer Narrative

An event regarding crack/fracture involving a tri cs insert tri sz4 11mm was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in used condition.There is damage on the bottom posterior side of the trial along the tab.The superior side has many scratches along the articulating surface and damage on the edges.Examination of the returned device with material analysis engineer noted the chipping observed is consistent with contact against the baseplate.Fragments are missing on the trial.-medical records received and evaluation: not performed as medical records were not provided for review.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the damage and chipping is consistent with contact against the baseplate.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

During wound closure of a total triathlon knee replacement, the surgeon showed me tiny flecks of green in the patient's tissue that were the same colour as the size 4 trial tibial insert, and that he attributed to breaking off the trial insert during trialling of the final sizes.

• Brand Name: MODIFIED HOLLOW CR TIBIAL INSERT TRIAL #4 - 11MM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6013577
• MDR Text Key: 57343988
• Report Number: 0002249697-2016-03200
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: 123486
• 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: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5530-T-411A
• Device Lot Number: PPM5G02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2010
• 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: 69 YR