MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; INSTRUMENT

Catalog Number UNK_REC

Device Problems Break (1069); Fracture (1260); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Occlusion (1984); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

During trialing of a triathlon total knee, the surgeon noticed pieces of plastic in knee joint.The surgeon trialed with a 9mm,11mm, and 13mm insert, after he removed each trial insert, he had to pick pieces of plastic out of patient's knee joint.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Conclusions: the reported event was confirmed.Chipping was observed on the distal rails of the triathlon cs insert trial.Scratches and indentations were observed on the articulating surface, underside, and distal rails.The observed damage likely occurred as a result of repeated use.

Event Description

During trialing of a triathlon total knee, the surgeon noticed pieces of plastic in knee joint.The surgeon trialed with a 9mm,11mm, and 13mm insert, after he removed each trial insert he had to pick pieces of plastic out of patients knee joint.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: INSTRUMENT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4592690
• MDR Text Key: 5447222
• Report Number: 0002249697-2015-00698
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: 30097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2007
• 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: 50 YR