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

Catalog Number	623-00-32F
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
After implanting trident cup into the patient, insert x3 liner.This fails after several attempts and it is believed that the size is incorrect.One opens a new package of the same size and fits directly.5-10 minutes delay in surgery due to this failure.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: the returned device was examined by an engineer who noted the following: damage observed on the insert consistent with implantation process and contact against a hard object.Scratches were also observed on the articulating surface of the insert.This is a common damage mode of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not 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.Further information such as the post operative x-rays and the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
After implanting trident cup into the patient, insert x3 liner.This fails after several attempts and it is believed that the size is incorrect.One opens a new package of the same size and fits directly.5-10 minutes delay in surgery due to this failure.

• 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: 8090376
• Report Number: 0002249697-2018-03774
• Device Sequence Number: 1436613
• Product Code: LPH
• UDI-Device Identifier: 07613327039474
• UDI-Public: 07613327039474
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 07/31/2023
• Device Catalogue Number: 623-00-32F
• Device Lot Number: 66374701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/26/2019
• 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