MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X46MM; 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	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: biomet act artic e1 hip brg 28x46mm, cat#ep-200152, lot#905880; biomet g7 dual mobility liner 46mm g, cat#110024465, lot#819050; biomet g7 screw 6.5mm x 35mm, cat#010001000, lot#6615769; biomet g7 bonemaster ltd acet shl 60g, cat#010000707, lot#6467781; depuy cementless femoral stem, cat#3l92501, lot#5360754; depuy biolox head, cat#1365-28-320, lot#9458351.Foreign country: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03063.
Event or Problem Description
It was reported the patient underwent a hip arthroplasty.Subsequently, patient was revised 1 month later due to hip dislocation.Surgeon discussed that the shell requires more version.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: b4, b5, g4, h2, h3, h6, h10.Reported event was confirmed by an image of explanted product.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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
No further event information available at the time of this report.

• Brand Name: ACT ARTIC E1 HIP BRG 28X46MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10368918
• Report Number: 0001825034-2020-03062
• Device Sequence Number: 19687292
• Product Code: LPH
• UDI-Device Identifier: 00880304485068
• UDI-Public: (01)00880304485068
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: 10/11/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-200152
• Device Lot Number: 905880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention