MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,

Model Number	509-02-58F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/31/2019
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
It was reported that the patient's left hip was revised due to dislocation of the adm/mdm poly insert from the mdm metal liner.The surgeon also wanted to medialize the acetabular shell.The mdm/ adm liner construct, ceramic head, sleeve (implanted (b)(6) 2019) and acetabular shell with 5 screws (implanted (b)(6) 2019) were revised to a larger shell, reimplantation of the 5 original screws (rep notified surgeon that this was off-label use), and femoral head with constrained liner.Rep confirmed there are no allegations against the revised head and sleeve, and confirmed that no further information will be available.

• Brand Name: TRITANIUM REVISION ACETABULAR
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9639815
• Report Number: 0002249697-2020-00166
• Device Sequence Number: 3444947
• Product Code: MBH
• UDI-Device Identifier: 07613327025170
• UDI-Public: 07613327025170
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 07/31/2022
• Device Model Number: 509-02-58F
• Device Catalogue Number: 509-02-58F
• Device Lot Number: 496JRA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/28/2020
• 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: 72 YR
• Patient Weight: 95