MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-32G
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Not available.
Event or Problem Description
Customer reported that the liner would not seat into the acetabular shell and would come away with the impactor.Stryker rep reported that the case is just happening, and the customer got another implant (same product code) and it has seated in the shell.There was a delay of approximately 15 minutes whilst attempting to seat the prosthesis and then proceeded to get another implant.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: the returned device was examined by an engineer who noted the following: damage observed on insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: could not be performed as no medical records were returned for review.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 were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including post operative x-rays and the primary operative report are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
Customer reported that the liner would not seat into the acetabular shell and would come away with the impactor.Stryker rep reported that the case is just happening, and the customer got another implant (same product code) and it has seated in the shell.There was a delay of approximately 15 minutes whilst attempting to seat the prosthesis and then proceeded to get another implant.

• Brand Name: TRIDENT 0° X3 INSERT 32MM 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: 8160195
• Report Number: 0002249697-2018-04030
• Device Sequence Number: 11313564
• Product Code: LPH
• UDI-Device Identifier: 07613327039481
• UDI-Public: 07613327039481
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033716
• 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): 04/17/2019

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: 05/31/2017
• Device Catalogue Number: 623-00-32G
• Device Lot Number: 59639001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 04/17/2019
• 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