MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	509-02-60F
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, it cannot be determined which one of the four reported screws allegedly fractured.Therefore, the event is being reported as an unknown screw and the device information provided for all four screws are as follows: 2080-0050/mkr9px, 2080-0030/mnex65, 2080-0020/mmrpwh x2.Reported event an event regarding malposition involving a trident shell 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: no medical records were received for review with a clinical consultant.Product history review: indicated 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 lot referenced.Conclusion: the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, 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.
Event or Problem Description
It was reported that the patient's hip was revised due to the shell being in a vertical position.Intra-operatively, a screw was found to be broken.Rep was not present in the operating room for removal of the acetabular components as the patient was being revised to competitor acetabular components and does not know which screw was broken.A shell, four screws, and a femoral head were revised to competitor acetabular components with a biolox head and sleeve.Rep confirmed there were no allegations made against the revised liner and head, provided the revision usage sheet, and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM REVISION ACETABULAR
• 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: 11633437
• Report Number: 0002249697-2021-00635
• Device Sequence Number: 3396707
• Product Code: LPH
• UDI-Device Identifier: 07613327025163
• UDI-Public: 07613327025163
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 06/30/2018
• Device Model Number: 509-02-60F
• Device Catalogue Number: 509-02-60F
• Device Lot Number: MMHAWV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/08/2021
• 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: 70 YR
• Patient Weight: 95