MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM DIA COCR MOD HD -3MM NK; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 11-165228-ringloc bi-polar 28x52mm-692240.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00592.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a hip revision approximately 3 days¿ post implantation due to dislocation.Patient had a fix hip and a ringloc bipolar cup was put in.Patient has dementia and when she woke up at night and did not know where she was she began thrashing and disassociated the 28mm head from the 52 bipolar cup construct.After attempts to reduce an x-ray was taken and the problem was noticed.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
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 the surgeon contributes the dislocation to the patient thrashing and moving around in the middle of the night.Therefore, there was no alleged product defect associated with the dislocation and the record will be updated to not a complaint.

• Brand Name: 28MM DIA COCR MOD HD -3MM NK
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11393484
• Report Number: 0001825034-2021-00591
• Device Sequence Number: 19679051
• Product Code: JDG
• UDI-Device Identifier: 00887868308260
• UDI-Public: (01)00887868308260(17)3000319(10)780250
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K942479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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 Model Number: N/A
• Device Catalogue Number: 163661
• Device Lot Number: 760250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR