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

Catalog Number	509-02-58F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	04/14/2018
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 events for the reported lot.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 through the submission of a revision implant sheet that patient's left hip was revised.5 restoration gap plate screws and a trident insert were implanted.Revision was for periprosthetic fracture of acetabulum.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a tritanium shell was reported.The event was not confirmed.Product evaluation and results: not performed as no product was returned for evaluation.No performed as no medical records were provided for review.Indicate all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There were no other reported events for the lot referenced.The event itself could not be confirmed nor could the exact cause of the event be determined because insufficient information was provided.Further information such as 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 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 through the submission of a revision implant sheet that patient's left hip was revised.5 restoration gap plate screws and a trident insert were implanted.Revision was for periprosthetic fracture of acetabulum.

• 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: 7502587
• Report Number: 0002249697-2018-01394
• Device Sequence Number: 16214172
• Product Code: LPH
• UDI-Device Identifier: 07613327025170
• UDI-Public: 07613327025170
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/04/2018

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: 02/28/2023
• Device Catalogue Number: 509-02-58F
• Device Lot Number: J32Y7J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: 72 YR