MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 51MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6226-2-651
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
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.If additional information is received, 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, there was a gap between a 52mm shell and a locking ring.Therefore, a surgeon decided to used 51mm but it was also same condition.
Event or Problem Description
It was reported that, during a bha, there was a gap between a 52mm shell and a locking ring.Therefore, a surgeon decided to used 51mm but it was also same condition.
Additional Manufacturer Narrative
Reported event an event regarding seating/locking issues involving a other hip head was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection - visual inspection of attached images was performed and stated that - no damage or scratches can be observed on the device.Device looks like in new condition.Functional testing performed using part number 6260-5-126 lot code 35578002.Failure mode was not confirmed during functional testing as the locking ring was able to be fully seated with femoral head assembled into bipolar component.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of attached images was performed and stated that - no damage or scratches can be observed on the device.Device looks like in new condition.Functional testing performed using part number 6260-5-126 lot code 35578002.Failure mode was not confirmed during functional testing as the locking ring was able to be fully seated with femoral head assembled into bipolar component.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CENTRAX DURATION 26MM X 51MM
• 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: 10300928
• Report Number: 0002249697-2020-01506
• Device Sequence Number: 16788565
• Product Code: JDI
• UDI-Device Identifier: 07613327032246
• UDI-Public: 07613327032246
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 08/31/2024
• Device Model Number: 6226-2-651
• Device Catalogue Number: 6226-2-651
• Device Lot Number: PR56J5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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