MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 41MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-641
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a bha, the v40 did not slide smoothly on the insert of the centrax.A spare head and centrax were used instead.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a centrax bipolar head was reported.The event was not confirmed.Method & results: device evaluation and results: a visual inspection indicated the centrax head was received along with the corresponding metal head and locking ring.No damage was observed on any of the components.Although there is some slight resistance when rotating the head within the centrax head, the head still moves freely within centrax head.A functional using a gauge could not be performed by operations engineer as head was returned assembled with the centrax head.Clinician review: not performed as medical records were not received for review with a clinical consultant.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 reported event was not confirmed nor can the root cause be determined.Although there is some slight resistance when rotating the head within the centrax head, the head still moves freely within centrax head.A functional using a gauge cannot be performed, indicating that the devices were returned assembled, therefore, they could not be re-inspected.Additionally, the product has met stryker's internal requirements.No further investigation for this event is needed.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 v40 did not slide smoothly on the insert of the centrax.A spare head and centrax were used instead.

• Brand Name: CENTRAX DURATION 26MM X 41MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7063146
• Report Number: 0002249697-2017-03424
• Device Sequence Number: 126359
• Product Code: JDI
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 07/08/2021
• Device Catalogue Number: 6226-2-641
• Device Lot Number: AT0239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 02/26/2018
• 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