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

Model Number	623-00-32D
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional 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 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.
Event or Problem Description
Revision surgery: update 22 january 2021: the surgeon reported that the revision was due to: trochanteric syndrome and trunnionosis.The patient felt pain.Head and liner explanted.Sleeve and biolox head implanted on damaged trunnion.Changed the liner to a 10 degree lip liner, and not proceeding to explant the well fixed femoral component.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion/trunnionosis involving an accolade stem and a metal head was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.Visual inspection was performed as part of the material evaluation and indicated the following comments: a small amount of damage from being in contact with a hard, sharp object, consistent with explantation is noted on the device.There is a no allegation of failure against this device which is a poly component and therefore cannot contribute to corrosion.A full complaint investigation is performed for the stem and head.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Revision surgery update 22 january 2021: the surgeon reported that the revision was due to: trochanteric syndrome and trunnionosis.The patient felt pain.Head and liner explanted.Sleeve and biolox head implanted on damaged trunnion.Changed the liner to a 10 degree lip liner, and not proceeding to explant the well fixed femoral component.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• Common Device Name: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11327468
• Report Number: 0002249697-2021-00259
• Device Sequence Number: 16349479
• Product Code: LPH
• UDI-Device Identifier: 07613327039467
• UDI-Public: 07613327039467
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 623-00-32D
• Device Catalogue Number: 623-00-32D
• Device Lot Number: JJ4P24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female