MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-28E
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: an event regarding seating locking issue involving a trident 0 degrees x3 insert 28mm id was reported.The event was not confirmed.The subject liner was returned in used condition.Review with the material analysis engineer indicated "markings were observed on the liner, consistent with in-service use." medical records received and evaluation: not performed because no patient clinical information was provided as there is no evidence to support the event was related to patient factors.Device history review: review of the device history records indicate that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.The event could not be confirmed as the reported device showed markings consistent with in-service use, therefore the functionality could not be duplicated.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
During tha surgery, the insert did not fit to the shell.The surgeon scraped the bones around the cup and inserted the another insert.

• Brand Name: TRIDENT 0° X3 INSERT 28MM 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: 6614643
• Report Number: 0002249697-2017-01789
• Device Sequence Number: 802727
• Product Code: LPH
• UDI-Device Identifier: 07613327039399
• UDI-Public: (01)07613327039399(11)160601(17)210531(10)7W3D04
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/06/2017

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: 05/31/2021
• Device Catalogue Number: 623-00-28E
• Device Lot Number: 7W3D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/06/2017
• 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: 43 YR