MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ6 - 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5530-T-611B

Device Problems Crack (1135); Fracture (1260); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The 6 by 11 tibial insert trial cracked when surgeon inserted it by hand pressure.He heard it crack and immediately ceased inserting it.The component was removed in tact with a visible crack.No patient consequences.The final implant insert was implanted successfully.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.-device evaluation and results: a crack was observed on the returned device.Material analysis was performed and concluded that "the fracture occurred in fast fracture through the center of the device.The origin was found to be inside the material at the interface between the first and second injection molding shots." -medical records received and evaluation: no medical records or x-rays were made available for evaluation.-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 no other event for the lot referenced.Conclusions: material analysis was performed and concluded that "the fracture occurred in fast fracture through the center of the device.The origin was found to be inside the material at the interface between the first and second injection molding shots." a capa investigation was initiated for the reported failure mode.The investigation concluded: the parts are injection molded by (b)(4).Sample parts were pulled from fg.Lack of fusion areas were observed between the first and second shots of the two-shot trials.

Event Description

A 6 by 11 tibial insert trial cracked when surgeon inserted it by hand pressure.He heard it crack and immediately ceased inserting it.The component was removed in tact with a visible crack.No patient consequences.The final implant insert was implanted successfully.

• Brand Name: TRIATHLON SOLID CR TIBIAL INSERT TRIAL SZ6 - 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6103088
• MDR Text Key: 60304612
• Report Number: 0002249697-2016-03595
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5530-T-611B
• Device Lot Number: KMAVR3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 65 YR
• Patient Weight: 48