MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 28 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	621-10-28F
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Surgeon could not impact insert 28f into trident size 56.
Additional Manufacturer Narrative
An event regarding an assembly issue involving a trident liner was reported.The assembly issue was not confirmed, however damage to the device was confirmed.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports are needed to fully investigate the event.If further information becomes available or this investigation will be re-opened.
Event or Problem Description
Surgeon could not impact insert 28f into trident size 56.

• Brand Name: TRIDENT 10° CROSSFIRE INSERT 28 MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7700797
• Report Number: 0002249697-2018-02223
• Device Sequence Number: 1065456
• Product Code: LPH
• UDI-Device Identifier: 07613327037753
• UDI-Public: 07613327037753
• Combination Product (Y/N): N
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 12/30/2019
• Device Catalogue Number: 621-10-28F
• Device Lot Number: 19TFC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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