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

Model Number	509-02-72I
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2021
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 arrived at (b)(6), ahead of their total knee replacement, but complained to dr of a sore hip.Patient was x-rayed, which showed the cup had come away from the acetabulum.Patient said they had lent forward and felt pain in their hip.Dr scheduled them for a revision acetabulum; instead of the tkr they were initially booked for.Dr contacted me and asked me to arrange revision cup items; he thought it was a depuy cup in situ.On (b)(6), just prior to starting the operation; dr said it was a tritanium cup.Which had been done as a revision shell in (b)(6) 2020.Dr said patient had rheumatoid arthritis and also a metabolic bone disease, that made the bone incredibly dense and was similar to osteogenesis petrosis.Dr said this was evident by the lack of bone growth on the shell, when it was explanted.

• 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: 11581018
• Report Number: 0002249697-2021-00552
• Device Sequence Number: 11973226
• Product Code: LPH
• UDI-Device Identifier: 07613327025231
• UDI-Public: 07613327025231
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 04/30/2023
• Device Model Number: 509-02-72I
• Device Catalogue Number: 509-02-72I
• Device Lot Number: TH8HRJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/29/2021
• 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