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

Model Number	6226-2-644
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that, during a bha, a head did not slide smoothly on the sliding surface of the reported centrax.Spare head and centrax were used instead.
Additional Manufacturer Narrative
Reported event: an event regarding a assembly issue involving centrax head was reported.The event was confirmed.-device evaluation and results: returned device has been assembled with femoral head.Polyethylene component would has been deformed as a result and in its current condition would not be an accurate reflection of its original manufactured condition.-clinician review: no medical records were received for review with a clinical consultant.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that, during a bha, a head did not slide smoothly on the sliding surface of the reported centrax.Return device has been assembled with femoral head.Polyethylene component would has been deformed as a result and in its current condition would not be an accurate reflection of its original manufactured condition.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be re-opened.
Event or Problem Description
It was reported that, during a bha, a head did not slide smoothly on the sliding surface of the reported centrax.Spare head and centrax were 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: 8773511
• Report Number: 0002249697-2019-02543
• Device Sequence Number: 16538575
• 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): 06/15/2020

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: 11/30/2023
• Device Model Number: 6226-2-644
• Device Catalogue Number: 6226-2-644
• Device Lot Number: 2X6J3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 06/15/2020
• 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