MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD +3MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown liner, 11-301323.Item name: arcos con sz c std 70mm.Lot #: 111160 11-300920.Item name: arcos 20x190mm spl tpr dist.Lot #: 941940.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2023 - 02359 the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.H3 other text : device location is unknown.
Event or Problem Description
It was reported that the patient underwent a revision procedure one month post implantation due to dislocation.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause of the reported issue is attributed to off-label usage as zimmer biomet products were used in conjunction with a competitor device.Zimmer biomet has not confirmed the compatibility of the reported combination of devices, and these would be considered off-label usages.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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
No further information at the time of this report.

• Brand Name: 36MM COCR MOD HD +3MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17921810
• Report Number: 0001825034-2023-02358
• Device Sequence Number: 14176476
• Product Code: JDI
• UDI-Device Identifier: 00880304210530
• UDI-Public: (01)00880304210530(17)270215(10)686470
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 12/20/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 11-363663
• Device Lot Number: 686470
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male