MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODIFIED HOLLOW CR TIBIAL INSERT TRIAL #5 - 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-509A

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 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Poly trial broke when inserting during a left total knee procedure.No adverse consequence to the patient.Procedure was completed successfully with an approximate 1 minute delay.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: device evaluation and results: the triathlon insert trial is fractured into two pieces.Examination of the returned device with material analysis engineer indicated the fracture surface was due to overload conditions and further assessment was not required.Medical records received and evaluation: not performed as medical records were not provided.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 is fractured into two pieces.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened and re-evaluated.An internal non conformance was issued to investigate the reported failure mode.The investigation concluded the possible root cause to be design deficiencies.

Event Description

Poly trial broke when inserting during a left total knee procedure.No adverse consequence to the patient.Procedure was completed successfully with an approximate 1 minute delay.

• Brand Name: MODIFIED HOLLOW CR TIBIAL INSERT TRIAL #5 - 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5866016
• MDR Text Key: 52495161
• Report Number: 0002249697-2016-02565
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5530-T-509A
• Device Lot Number: PPMAM54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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: 47 YR