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
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Scratched Material (3020); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6873698
• Report Number: 0002249697-2017-02813
• Device Sequence Number: 1365170
• Product Code: MBH
• UDI-Device Identifier: 07613327032147
• UDI-Public: 07613327032147
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other