MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.; PROTHESIS HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.D10: cat#: 65620005821, lot #: 63382517 shell porous without holes 58 mm o.D.Cat#: 00811400410, lot #: 63724908 femoral stem12/14 neck taper.Cat#: 4000-8775-036-04, lot #: 2890293 delta ceramic femhead + 7 36mm.Cat#: 00801102028, lot #: 63862008 allen medullary cement plugs.Customer indicated that the product will not be returned to zimmer biomet for investigation.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.The reported issue cannot be confirmed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that approximately 4 years post implantation of a right total hip arthroplasty, the patient was revised due to dislocation.No additional information available.

• Brand Name: TRILOGY LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.
• Common Device Name: PROTHESIS HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19086584
• Report Number: 0002648920-2024-00101
• Device Sequence Number: 12717861
• Product Code: LPH
• UDI-Device Identifier: 00889024124813
• UDI-Public: (01)00889024124813(17)210731(10)63417809
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00631005836
• Device Lot Number: 63417809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male