MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 41MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6226-2-641

Device Problems Device Operates Differently Than Expected (2913); Scratched Material (3020); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicates the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that, during a bha, the centrax could not slide smoothly on the v40 head.Therefore, a spare centrax was used instead with the v40.

Manufacturer Narrative

An event regarding "seating/locking issue" involving a centrax bipolar was reported.The event was not confirmed.Device evaluation and results: the centrax head was received along with the external box, external blister, ifu, implant label, corresponding locking ring and packaging clip.Scratches observed on the articulating surface of the bipolar are consistent with attempted use.A functional test was performed with the returned device along with a 26mm -3 v40 taper vit head obtained from finished goods.The head was assembled to the returned device with normal hand force and without any undue effort.Once assembled, the head freely rotated.Medical records received and evaluation: not performed as no patient information was received, no adverse consequences to the patient were noted.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the reported lot.Conclusions: the event could not be confirmed as it was determined that the device was fully functional as per the functional test performed.The device was deemed to be conforming and therefore, the reported event could not be duplicated.No further investigation for this event is possible at this time.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that, during a bha, the centrax could not slide smoothly on the v40 head.Therefore, a spare centrax was used instead with the v40.

• Brand Name: CENTRAX DURATION 26MM X 41MM
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6873698
• MDR Text Key: 86512635
• Report Number: 0002249697-2017-02813
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327032147
• UDI-Public: 07613327032147
• Combination Product (y/n): N
• PMA/PMN Number: K972792
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Catalogue Number: 6226-2-641
• Device Lot Number: 6J5N24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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