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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
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.Not returned.
Event or Problem Description
Liner dislocation after one month of implantation.The liner was revised.Update from rep: liner dislocated from shell.
Event or Problem Description
Liner dislocation after one month of implantation.The liner was revised.Update from rep: liner dislocated from shell.
Additional Manufacturer Narrative
Corrected data.Lot code was corrected based on the received device.An event regarding disassociation of the liner from the shell component involving a trident liner was reported.Method & results: device evaluation and results: visual inspection of the returned device indicates damage in a number of areas.Damage was noted on the outer surface which would have been in contact with the shell component.These indentations may be indicative of some obstruction that the liner came into contact with when it was being impacted into the shell component.Damage was also noted on the outer lip of the insert and on the edges of the shell and on the raised area which would lock into shell.The damage on the lip of the component is consistent with the reported event that the liner disassociated in vivo and was subsequently explanted.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: visual inspection of the returned device indicates damage in a number of areas.Damage was noted on the outer surface which would have been in contact with the shell component.These indentations may be indicative of some obstruction that the liner came into contact with when it was being impacted into the shell component.Damage was also noted on the outer lip of the insert and on the edges of the shell and on the raised area which would lock into shell.The damage on the lip of the component is consistent with the reported event that the liner disassociated in vivo and was subsequently explanted.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, post-operative x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• 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: 7872313
• Report Number: 0002249697-2018-02849
• Device Sequence Number: 19459717
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2023
• Device Catalogue Number: 623-10-32E
• Device Lot Number: NA3JRY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: Hospitalization; Required Intervention