MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-652
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
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 locking ring was not locked due to tightness.
Additional Manufacturer Narrative
An event regarding ¿during a bha, the locking ring was not locked due to tight¿ (size/fit issue) involving a centrax head was reported.The event was not confirmed.A visual inspection was conducted and the device was returned without the green shipment ring.The ring was slightly seated on an angle in the bipoloar prosthesis.A dimensional inspection was completed by an operations engineer in the packaging cell stated that, ¿the returned centrax product was re-inspected with functional gage and found to be confirming as per specification.A functional test was performed with the returned device, centrax duration 26mm x 52mm.A v40 femoral head, lfit v40 femoral head, pulled from finished goods and a sample stem was used to determine if the reported event was confirmed or not confirmed.The v40 head was placed to the stem and the v40 femoral head.The v40 femoral head was snapped into place within the insert of the bipolar head.The locking ring was pushed down and locked into the bipolar assemblies insert.The v40 femoral head rotated within the bipolar insert as intended.Medical records received and evaluation: not performed because no medical records or x-rays were made available for evaluation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.The reported event of ¿during a bha, the locking ring was not locked due to tight¿ was not confirmed.A dimensional inspection was completed by an operations engineer in the packaging cell stated that the device was in specification.A functional test was conducted and the device was able to be assembled and the locking ring snapped into the insert of the device.The femoral head was able to move as intended.The root cause could not be determined at this time because the femoral head used was not returned.There could not be a determination if the correct size head was used or the condition of the device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that, during a bha, the locking ring was not locked due to tightness.

• Brand Name: CENTRAX DURATION 26MM X 52MM
• 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: 7142458
• Report Number: 0002249697-2017-03668
• Device Sequence Number: 939726
• Product Code: JDI
• UDI-Device Identifier: 07613327032253
• UDI-Public: 07613327032253
• 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): 03/23/2018

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: 04/14/2021
• Device Catalogue Number: 6226-2-652
• Device Lot Number: L2122H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/23/2018
• 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