MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22D; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
During attempt to implant, the constrainer liner was damaged (dents and markings).The liner would not lock into the shell.There was no damage to the "in and out" head but it was inserted in the constrained liner so surgeon decided to use a new constrained liner and head.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving an trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: 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 event could not be confirmed nor could the root cause be determined because the insufficient medical information was provided.Further information such as return of device, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
During attempt to implant, the constrainer liner was damaged (dents and markings).The liner would not lock into the shell.There was no damage to the "in and out" head but it was inserted in the constrained liner so surgeon decided to use a new constrained liner and head.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22D
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6363248
• Report Number: 0002249697-2017-00692
• Device Sequence Number: 1225909
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: (01)07613327025538(11)161027(17)211031(10)ME63JJ
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• 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): 05/25/2017

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: 10/31/2021
• Device Catalogue Number: 690-00-22D
• Device Lot Number: ME63JJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 05/25/2017
• 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: 54 YR
• Patient Weight: 58