MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-650
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that, during a bha, the locking ring was not locked with the shell.A centrax (1 mm under size) was used instead.
Additional Manufacturer Narrative
An event regarding assembly issues involving a centrax head was reported.The event was not confirmed.Method & results: device evaluation and results: the centrax head was received along with the corresponding locking ring and packaging green clip.No visible damage was observed on any of the components.A functional test was performed with the returned device along with a 26mm std lfit v40 head, cat: 6260-9-126, lot: 62522102, and an accolade (127 deg) sample, catalog no.: w6021-0335 were obtained from finished goods.The returned device was readily assembled to these components with normal hand force and without any resistance.Once assembled, the metal head rotated freely in the returned centrax insert as required.The returned centrax head was also inspected using a pin gauge, ma-02538 per the drawing# pe-9008-7-040 and the device passed inspection.The device was deemed to be conforming and therefore, the reported event could not be duplicated.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event nor the root cause could not be confirmed as it was determined that the device was fully functional as per the functional tests performed.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that, during a bha, the locking ring was not locked with the shell.A centrax (1 mm under size) was used instead.

• Brand Name: CENTRAX DURATION 26MM X 50MM
• 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: 8245312
• Report Number: 0002249697-2019-00170
• Device Sequence Number: 19405172
• Product Code: JDI
• UDI-Device Identifier: 07613327032239
• UDI-Public: 07613327032239
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 04/30/2023
• Device Catalogue Number: 6226-2-650
• Device Lot Number: 633V0X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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
• Patient Age: 80 YR
• Patient Weight: 50