MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR STD NECK; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374); Subluxation (4525)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the patient had an initial right total hip arthroplasty the patient experienced dislocation and subluxation resulting in closed repositioning.No further compilations have been reported and the patient remains very satisfied with his new joint at this time.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item #: 010000851 item name: g7 neutral e1 liner 32mm g lot number: 3387421.Item #: 192015 item name: echo por fmrl nc 15x155mm lot number: 534880.Item #: 010000667 item name: g7 pps ltd acet shell 60g lot number: 3441508.Unk lot unk apical plug.Report source: foreign: denmark.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00037.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Head - review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation and subluxation, closed repositioning on (b)(6) 2021.No issues, pain, or discomfort on (b)(6) 2022.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
There is no update to the previous event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent a revision procedure 8 years and 1 month post implantation due to recurrent dislocation and subluxation.The head and liner were exchanged.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4.G3.G6.H2.H6 component code: mechanical (g04) - head.H11.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following additional information: dislocation and subluxation after a fall and for a second time after bending in a seated position.Subsequently, the patient was revised, head and liner were exchanged.Root cause is unchanged.Complaint confirmed due to medical records.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.

• Brand Name: 32MM MOD HEAD COCR STD NECK
• 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: 16112605
• Report Number: 0001825034-2023-00036
• Device Sequence Number: 5655518
• Product Code: JDG
• UDI-Device Identifier: 00887868308338
• UDI-Public: (01)00887868308338(17)250707(10)00J3600508
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K942479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup,Followup,Followup
• Report Date (Section B): 08/22/2024

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: Lay User/Patient
• Device Expiration Date: 06/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 163669
• Device Lot Number: 00J3600508
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/01/2023; 04/26/2024; 08/21/2024
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/02/2023; 05/22/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2015
• 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 FOR ALL DEVICES.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 80 KG