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

Model Number	509-02-62G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/08/2020
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
Patient dislocated anteriorly (on (b)(6)) following a revision hip replacement.Revision was on (b)(6) 2020, to remove a mittlemeier type screw in cup (smith & nephew brand).There was a lot of osteolysis behind the cup & cup was revised to a tritanium revision shell with mdm.On standby at this revision on (b)(6) was a smith and nephew cage and a constrained cemented cup (stryker).The doctor decided not to use the cage and constrained cup, stating that the hip felt stable with the tritanium and mdm construct.Late on the night of (b)(6), i received a call to say that patient was dislocating & they were going to revise to a cage.Tritanium cup and mdm was removed; smith & nephew cage put in with a stryker all-poly constrained cup.There was no surgical delay or adverse consequences for the patient.The doctor wanted to ¿rough up¿ the back of the all poly constrained cup, i told him this was off-label.The doctor used the bone nibblers on the back of the cup; where the cement interface was.Patient is female, over 70 years old, operative side is right hip.

• 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: 10210831
• Report Number: 0002249697-2020-01330
• Device Sequence Number: 19500225
• Product Code: LPH
• UDI-Device Identifier: 07613327025187
• UDI-Public: 07613327025187
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: 07/31/2024
• Device Model Number: 509-02-62G
• Device Catalogue Number: 509-02-62G
• Device Lot Number: D654PM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/30/2020
• 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: 70 YR