MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 CERMC HD 22.2MM X +0; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately 10 months post implantation due to recurrent dislocation and instability.After the procedure, the patient had good range of motion without impingement or tendency to dislocation.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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 proposed component code: mechanical (g04)- head.H10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record 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: an initial right tha was performed in 2012 with competitor products and the patient has a history of ra and scoliosis.A revision occurred due to recurrent dislocations, where a mix of zb and competitor products were implanted.A few months later, the patient bent over and dislocated again, with another revision on jan 11, 2023, with a mix of zb and competitor products.The patient experienced another dislocation between the competitor shell and constrained liner, and was revised on jul 19, 2023.All implants except the zb stem were revised, and all zb products were placed.Images assessed but not sent to mmi for review as revision op notes contain sufficient dictation of findings.No problem was found with the head.While if it is unknown if the off label usages caused or contributed to the reported events, no problem was found with the head as the dislocations were reported to be occurring between the competitor liner and shell.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: ZB 12/14 CERMC HD 22.2MM X +0
• Common Device Name: PROSTHETIC, HIP
• 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: 17567169
• Report Number: 0001822565-2023-02215
• Device Sequence Number: 6694348
• Product Code: JDI
• UDI-Device Identifier: 00887868376320
• UDI-Public: (01)00887868376320(17)310228(10)3068211
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 802602202
• Device Lot Number: 3068211
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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: UNKNOWN STRYKER LINER, SHELL AND SCREWS
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 61 KG