MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X44MM; PROSTHESIS, HIP M H

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number:110024464 lot number: 372990 brand name: g7 dual mobility liner 44mm f, catalog number:31-323240 lot number: 026700 brand name: 3.2mmx40mm rnglc, catalog number:110010266 lot number:6680970 brand name: g7 acetabular shell.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01754.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
Event or Problem Description
It was reported that the patient was revised due to dislocation approximately 2 months post implantation.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was confirmed by review of photographs provided.Review of the photographs show the devices separated, with blood stains.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp).Impressions: 1.Left total hip arthroplasty with cement fixation of the left acetabular cup.No radiolucency.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 28X44MM
• Common Device Name: PROSTHESIS, HIP M H
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9981014
• Report Number: 0001825034-2020-01755
• Device Sequence Number: 3836443
• Product Code: KWY
• UDI-Device Identifier: 00880304485051
• UDI-Public: (01)00880304485051(17)241017(10)935390
• 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): 07/10/2020

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: 10/17/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-200150
• Device Lot Number: 935390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/04/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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
• Patient Age: 87 YR
• Patient Weight: 60