MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 36 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	621-10-36G
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Discomfort (2330); Metal Related Pathology (4530)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2014 and was revised on (b)(6) 2020.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update as per medical review (b)(6) 2022.Intraoperative findings included "black fluid corrosion at trunnion and femoral head inner surface, healthy appearing muscle, well fixed components, significant wear in the posterior superior rim of the acetabular polyethylene.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event of corrosion was confirmed through clinician review of the provided records.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 6 years after implantation due to trunnion corrosion and elevated ion levels.Intraoperative findings included "black fluid corrosion at trunnion and femoral head inner surface, healthy appearing muscle, well fixed components, significant wear in the posterior superior rim of the acetabular polyethylene.I can confirm that this event took place since i was able to review the operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion corrosion are multifactorial including surgical technique factors, patient factors and implant factors.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.Conclusion: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a total hip replacement about 6 years after implantation due to trunnion corrosion and elevated ion levels.Intraoperative findings included "black fluid corrosion at trunnion and femoral head inner surface, healthy appearing muscle, well fixed components, significant wear in the posterior superior rim of the acetabular polyethylene.I can confirm that this event took place since i was able to review the operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion corrosion are multifactorial including surgical technique factors, patient factors and implant factors.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and 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.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 10° CROSSFIRE INSERT 36 MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14276090
• Report Number: 0002249697-2022-00644
• Device Sequence Number: 20043903
• Product Code: LZO
• UDI-Device Identifier: 07613327023725
• UDI-Public: 07613327023725
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K991952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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: 01/31/2018
• Device Model Number: 621-10-36G
• Device Catalogue Number: 621-10-36G
• Device Lot Number: MMAYEH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male