MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-644
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other 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; when the surgeon combined the centrax and v40 head, the centrax did not slide smoothly.A spare centrax was used instead.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a centrax bipolar head was reported.The event was not confirmed.A visual inspection indicated the centrax head was received with the locking ring disassembled.A material analysis engineer noted, "scratches observed consistent with the implantation and/or explantation processes observed on device." although there is some slight resistance when rotating the head within the centrax head, the head still moves freely within centrax.Head.A functional test was performed on the received device with a calibrated gage and metal head and was found to rotate freely.Clinician review: not performed as medical records were not received for review with a clinical consultant.All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.The reported event was not confirmed nor can the root cause be determined.A functional inspection was performed by the operations engineer which confirmed the metal head moves freely within the centrax head.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; when the surgeon combined the centrax and v40 head, the centrax did not slide smoothly.A spare centrax was used instead.

• Brand Name: CENTRAX DURATION 26MM X 44MM
• 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: 7300562
• Report Number: 0002249697-2018-00561
• Device Sequence Number: 1236957
• Product Code: JDI
• UDI-Device Identifier: 07613327032178
• UDI-Public: 07613327032178
• 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): 05/18/2018

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: 09/30/2022
• Device Catalogue Number: 6226-2-644
• Device Lot Number: 312VVH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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