MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ADJUSTMENT HOUSING - 3° SLOPE; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 6541-2-705

Device Problems Device Operates Differently Than Expected (2913); Material Distortion (2977); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The bronze colored wheel of the tibial adjustment housing does not give resistance (drag) when reaching the necessary height of resection.

Manufacturer Narrative

An event regarding wear involving a tibial adjustment housing was reported.Conclusions: the device was discovered during inspection.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.The device was returned in used condition.There are minor scratches and abrasions in various areas of the device.The inner threads of the device look worn.A functional test was conducted with the returned device catalog 6541-2-705 tibial adjustment housing ¿ 3 degree slope, lot code af4a07 with catalog 6541-2-611 tibial alignment proximal rod em lot rd5l280 and catalog 6541-2-610 distal assembly ¿ ankle clamp triathlon instrument lot rd6h078.The tibial adjustment housing was assembled to the proximal rod assembly and then the distal assembly ¿ ankle clamp was assigned to the proximal rod.During the functional inspection the tibial adjustment housing moved freely up and down the tibial alignment proximal rod.The adjustment housing did not lock properly onto the proximal rod.When engaging the thumb wheel it did move up and down as intended.With force the threads did not lock onto the proximal road allowing it to move up and down.¿ma: wear observed on threads of device.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ the event was confirmed based on the functional inspection conducted and the material analysis review.The root cause of the wear was due to the inner threads of the tibial adjustment housing were worn causing it to not hold its place on the proximal rod assembly.

Event Description

The bronze colored wheel of the tibial adjustment housing does not give resistance (drag) when reaching the necessary height of resection.

• Brand Name: TIBIAL ADJUSTMENT HOUSING - 3° SLOPE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7071568
• MDR Text Key: 93566470
• Report Number: 0002249697-2017-03450
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K172326
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-705
• Device Lot Number: AF4A07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2009
• 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