MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI CS INSERT TRL SZ5 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531-T-509

Device Problems Break (1069); Crack (1135); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Rep reported 3 trial poly inserts cracked/chipped during surgery.Few minutes of delay due to breakage of inserts.Will need to order new poly inserts.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon trial was reported.The event was confirmed.Method & results: device evaluation and results: the reported event was confirmed.Chipping was observed on the distal rails of the triathlon insert trial.Scratches and indentations were observed on the articulating surface, underside, and distal rails.Mar engineer indicated that damage observed on trial consistent with contact against a hard object.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: the event was confirmed.Chipping was observed on the distal rails of the triathlon insert trial.Scratches and indentations were observed on the articulating surface, underside, and distal rails.A material analysis has been performed.The report indicated the damage was observed on trial consistent with contact against a hard object.

Event Description

Rep reported 3 trial poly inserts cracked/chipped during surgery.Few minutes of delay due to breakage of inserts.Will need to order new poly inserts.

• Brand Name: TRI CS INSERT TRL SZ5 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: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6226875
• MDR Text Key: 64256720
• Report Number: 0002249697-2017-00097
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5531-T-509
• Device Lot Number: 893309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2011
• 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