MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B200

Device Problems Delivered as Unsterile Product (1421); Particulates (1451); Tear, Rip or Hole in Device Packaging (2385); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

The product was opened and the primary packaging containing the implant was given to the circulating nurse.A pin hole was discovered on the top part of the package.There was no defect on the secondary packaging.The implant revealed some kind of particulate.Particulates on the rim of base plate were found.Surgeon did not want to contaminate the field.He was concerned that the implant was unsterile.

Manufacturer Narrative

The device was not returned for evaluation.An event regarding packaging damage involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as no product was returned.Medical records received and evaluation: not performed as no medical records were received, the event relates to a packaging issue.-device history review: indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusion: the exact cause of the event could not be determined as no product was returned for analysis.If packaging and / or additional information become available, this investigation will be reopened.Device not returned.

Event Description

The product was opened and the primary packaging containing the implant was given to the circulating nurse.A pin hole was discovered on the top part of the package.There was no defect on the secondary packaging.The implant revealed some kind of particulate.Particulates on the rim of base plate were found.Surgeon did not want to contaminate the field.He was concerned that the implant was unsterile.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #2
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5999311
• MDR Text Key: 56447174
• Report Number: 0002249697-2016-03172
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 5520B200
• Device Lot Number: AXB7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 67