MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CR TIBIAL INSERT TRIAL #4 - 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 5530-T-413

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Broken cr insert trial discovered during trial reduction with implants in.

Manufacturer Narrative

Device returned.An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: device evaluation and results: the visual inspection of the returned device noted that triathlon insert trial was fractured into two pieces, fractured part also returned.Examination of the returned device with material analysis engineer indicated the fracture is consistent with overload condition as indicated by hackles.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 events for the lot referenced.Conclusions: the returned device confirms the reported event of a fractured trial.The investigation concluded the reported event is the result of a design issue.To address this issue, a design change occurred in 2010 to obsolete this product and create a new replacement product.No further investigation is required at this time.

Event Description

Broken cr insert trial discovered during trial reduction with implants in.

• Brand Name: CR TIBIAL INSERT TRIAL #4 - 13MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6382277
• MDR Text Key: 69205710
• Report Number: 0002249697-2017-00787
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123166
• 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: 05/31/2017

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: 5530-T-413
• Device Lot Number: PPM1Z26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2007
• 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: 64 YR