MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	625-0T-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Rep received a message from a physician assistant that patient's hip was observed to have a fractured ceramic liner and will be revised.As of the time of report, rep was given a lot code for a trident e ceramic insert/sleeve and was not made aware of the revision plan or any other pre-operative findings.Patient is scheduled for revision on (b)(6) 2019.Rep may be able to provide operative report(s) and usage sheet(s) when the revision is performed.Hospital and surgeon has no access to further information.Update (b)(6) 2019: spoke to rep.Original patient complaint was a grinding sensation in the hip.Intra-operatively, none of the implants were found to have fractured.The ceramic liner and femoral head were revised to an x3 0° 32 d poly liner and 32 +5 head with sleeve.There are no allegations against the femoral head.
Additional Manufacturer Narrative
Correction: update to catalog and lot numbers.An event regarding revision surgery involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: cannot confirm event, need additional information; revision operative report, clinical and past medical history, serial dated x-rays and examination of explanted components.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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including revision operative reports, clinical and past medical history, serial dated x-rays and return of the device are needed to fully investigate the event.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Rep received a message from a physician assistant that patient's hip was observed to have a fractured ceramic liner and will be revised.As of the time of report, rep was given a lot code for a trident e ceramic insert/sleeve and was not made aware of the revision plan or any other pre-operative findings.Patient is scheduled for revision on (b)(6) 2019.Rep may be able to provide operative report(s) and usage sheet(s) when the revision is performed.Hospital and surgeon has no access to further information.Update 23/october/2019 wg: spoke to rep.Original patient complaint was a grinding sensation in the hip.Intra- operatively, none of the implants were found to have fractured.The ceramic liner and femoral head were revised to an x3 0° 32 d poly liner and 32 +5 head with sleeve.There are no allegations against the femoral head.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9310919
• Report Number: 0002249697-2019-03734
• Device Sequence Number: 18949602
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 08/31/2009
• Device Model Number: 625-0T-32E
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: 10362501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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
• Patient Age: 65 YR