MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X54MM; 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	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical devices: item number 00801802802 item name femoral head sterile product do not resterilize 12/14 taper lot # 64455813; item number 00811400210 item name femoral stem 12/14 neck taper ext.Offset size 2 130 mm stem length lot # 64441079.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record of the bearing identified no deviations or anomalies during manufacturing.Operative notes were not provided; xrays were provided and reviewed by a healthcare professional.Ap pelvis film demonstrates a right total hip arthroplasty with cement fixation of the acetabular cup.Superior and likely posterior dislocation of the right femoral head.No signs of loosening, wear or radiolucency.No fracture.It was reported that the patient's blood alcohol level was 0.3 (severe intoxication) at the time of the fall which may have contributed to the reported event, however 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.  multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04435.
Event or Problem Description
It was reported patient underwent a revision procedure approximately nine months post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ACT ARTIC E1 HIP BRG 28X54MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11831541
• Report Number: 0001825034-2021-01490
• Device Sequence Number: 19878678
• Product Code: LPH
• UDI-Device Identifier: 00880304485051
• UDI-Public: (01)00880304485051(17)230410(10)012620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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 Expiration Date: 04/10/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-200150
• Device Lot Number: 012620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/17/2021
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 98