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	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
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.It was noted that the device is not available for evaluation.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
Unable to lock the ring while removing the green locking ring and using the centranx forceps to attach it to the head.As a result of confirmation, a part of polyethylene was broken.Used another size cup.
Additional Manufacturer Narrative
An event regarding crack/fracture of a centrax head during implantation was reported.The event was not confirmed.Conclusion: three photographs of the component were provided for review.Damage consistent with attempted assembly is observed on the poly of the head but the reported fracture of the poly is not visible, therefore not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including evaluation of the device and the operative report are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Unable to lock the ring while removing the green locking ring and using the centranx forceps to attach it to the head.As a result of confirmation, a part of polyethylene was broken.Used another size cup.

• 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: 7926670
• Report Number: 0002249697-2018-03143
• Device Sequence Number: 1346775
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 05/31/2023
• Device Catalogue Number: 6226-2-650
• Device Lot Number: 1T6KW1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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
• Patient Age: 38 YR
• Patient Weight: 70