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

Model Number 623-10-32D

Device Problems Degraded (1153); Material Discolored (1170)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Metal Related Pathology (4530)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Event Description

Left hip washout and head and liner change secondary to infection.Doctor noted signs of mechanical wear/early metalosis of the head and discolouration of the poly liner.

Manufacturer Narrative

Reported event: an event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has yellow discoloration.The yellow discoloration is consistent with the absorption of synovial fluid by the device.Additional damage in the form of a "tear" in the rim of the liner and significant scratches are observed.Damage is consistent with attempted explantation.Material analysis: material analysis is not required as the yellow discoloration is consistent with absorption of synovial fluid by the device.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray demonstrated bilateral tha in anatomic position without evidence of loosening or mechanical complication.The brief operative note described an i and d with liner and head exchange undertaken due to infection.Revision head and liner exchange with an i and d is confirmed." product history review: review of the device history records indicate 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 lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.Discoloration of the liner was observed intraoperatively.Visual inspection of the returned device indicated that the device has yellow discoloration.The yellow discoloration is consistent with the absorption of synovial fluid by the device.Additional damage in the form of a "tear" in the rim of the liner and significant scratches are observed.Damage is consistent with attempted explantation.A review of the provided medical information by a clinical consultant did not confirm the infection event.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, the primary/revision operative reports, and 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.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Left hip washout and head and liner change secondary to infection.Doctor noted signs of mechanical wear/early metalosis of the head and discolouration of the poly liner.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13518845
• MDR Text Key: 285620270
• Report Number: 0002249697-2022-00214
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 623-10-32D
• Device Catalogue Number: 623-10-32D
• Device Lot Number: 7P889V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female