MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-44F
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported "cone wear of the hip stem".Additional information from the surgeon: revision right hip tep via dorsal approach was performed on (b)(6) 2021.Analysis of the joint: metalosis, cone of the hip stem used up, pe inlay damaged, cup trident x3 /58mm fixed, head cocr 44mm/v40cone.Removal of the hip stem via transfemoral approach.The cone of the femoral stem was used up.The femoral head is luxated.Head disassociation from the femoral stem.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be 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 revision of a total hip replacement due to head disassociation from the femoral stem with evidence of trunnion deformity and wear.I can confirm that this event took place since i was able since i was able to see the implant removed.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion deformity and wear are multifactorial including implant factors, surgical technique factors and patient factors.Product history review: review of the device history records indicate the 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.Conclusions: it was reported that the patient was revised due to disassociation of the head from the stem.Liner wear/damage was also reported.A review of the provided medical information by a clinical consultant confirmed the disassociation event, but there was insufficient information to confirm wear of the trident liner.Further information such as return of the device/photographs of the device, and the primary/revision 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 0 DEG INSERT 44MM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14748363
• Report Number: 0002249697-2022-00867
• Device Sequence Number: 4728504
• Product Code: LPH
• UDI-Device Identifier: 07613327025422
• UDI-Public: 07613327025422
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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: 05/31/2017
• Device Model Number: 623-00-44F
• Device Catalogue Number: 623-00-44F
• Device Lot Number: MLJ27W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2012
• 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: 61 YR
• Patient Sex: Male