MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-01-48D
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	02/02/2018
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
It was reported patient's hip was revised due to shell loosening.Rep was not present for the procedure.
Additional Manufacturer Narrative
Device evaluated by mfg.An event regarding loosening involving a trident shell was reported.The event was not confirmed.Device evaluation and results: not performed as product was not returned no medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided and the device was not returned.Further information such as product evaluation, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause 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
It was reported patient's hip was revised due to shell loosening.Rep was not present for the procedure.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7309518
• Report Number: 0002249697-2018-00612
• Device Sequence Number: 1355063
• Product Code: LPH
• UDI-Device Identifier: 07613153073062
• UDI-Public: 07613153073062
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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: 07/31/2022
• Device Catalogue Number: 502-01-48D
• Device Lot Number: 60409401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/02/2018
• 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: 57 YR
• Patient Weight: 69