MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	623-10-32E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Customer reported that during a thr, the surgeon stephen had implanted a tritanium primary shell, however when he tried to impact the 32 10 degree trident liner into the shell, it wouldn't lock in.Another implant from the shelf was used to complete the case and there was only a delay of few minutes.
Additional Manufacturer Narrative
An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: examination of the returned device by an engineer noted the following: damage observed on outer rim of insert consistent with implantation and explantation process.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 information was received.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 primary operative report as well as patient history and follow-up notes 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 becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Customer reported that during a thr, the surgeon stephen had implanted a tritanium primary shell, however when he tried to impact the 32 10 degree trident liner into the shell, it wouldn¿t lock in.Another implant from the shelf was used to complete the case and there was only a delay of few minutes.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7960716
• Report Number: 0002249697-2018-03310
• Device Sequence Number: 1572423
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 04/30/2023
• Device Catalogue Number: 623-10-32E
• Device Lot Number: J47AT0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 03/04/2019
• 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