MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5515-F-601

Device Problems Metal Shedding Debris (1804); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

Ps cemented femoral prosthesis opened from sterile packaging.Scrub nurse has noticed debris in lateral posterior condyle screw hole of prosthesis.Surgeon notified immediately.Debris removed and prosthesis implanted as per technique.

Manufacturer Narrative

Product available to stryker.Device evaluated by mfg.An event regarding foreign matter involving a triathlon ps femoral component, cemented was reported.The event was confirmed.Device evaluation and results:the mar concluded characterisation using stero microscopy, electron microscopy and infrared spectroscopy confirmed debris residue as combination of entangled fibres of cotton fabric with aluminium oxide and traces of cobalt and chromium.The cotton is consistent with mop material used as polishing support for aluminium oxide polishing media.Cobalt and chromium are attributed to co-cr base alloy of femoral.Medical records received and evaluation: not performed as no medical records were provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the reported lot referenced.The mar indicated that: characterisation using stero microscopy, electron microscopy and infrared spectroscopy confirmed debris residue as combination of entangled fibres of cotton fabric with aluminium oxide and traces of cobalt and chromium.The cotton is consistent with mop material used as polishing support for aluminium oxide polishing media.Cobalt and chromium are attributed to co-cr base alloy of femoral.Nc was raised on the (b)(6) 2017 to investigation this issue further.The nc investigation determined that this is an isolated event.No further investigation is possible at this time.

Event Description

Ps cemented femoral prosthesis opened from sterile packaging.Scrub nurse has noticed debris in lateral posterior condyle screw hole of prosthesis.Surgeon notified immediately.Debris removed and prosthesis implanted as per technique.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6767202
• MDR Text Key: 81820544
• Report Number: 0002249697-2017-02373
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Catalogue Number: 5515-F-601
• Device Lot Number: AHR9X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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: 63 YR
• Patient Weight: 84