MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR HD 32MM X +0; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Dislocation (2374)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a hip arthroplasty.Subsequently, the patient was revised one year post implantation due to dislocation due to placement of the acetabular component.The head, liner, and shell were exchanged.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 4265 allofit-s alloclas shell 52/ii 3065418.01.00013.509 dural alpha insert w rim ii/32 3060690.G2: report source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical (g04)- head.Visual examination of the provided pictures identified the construct still assembled after explant, and then subsequently separated.The devices are covered in bio-debris.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the left hip arthroplasty without dislocation.A definitive root cause cannot be determined.Implant placement is the surgeon's discretion.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: ZB 12/14 COCR HD 32MM X +0
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19006038
• Report Number: 0001822565-2024-01081
• Device Sequence Number: 9372657
• Product Code: LPH
• UDI-Device Identifier: 00889024498839
• UDI-Public: (01)00889024498839(17)300930(10)3047396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 06/11/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 802203202
• Device Lot Number: 3047396
• 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: 03/09/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male