MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X38MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); 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 products:: item number 00811400110 item name femoral stem 12/14 neck taper ext.Offset size 1 130 mm stem length lot # 64609268.Item number 010000701 item name g7 bonemaster ltd acet shl 48c lot # 6749838.Item number 00801802803 item name femoral head sterile product do not resterilize 12/14 taper lot # 62516835.Product returned to zimmer biomet for investigation.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 - 04439.
Event or Problem Description
It was reported patient underwent a hip revision procedure approximately one month post implantation due to dislocation.Patient fell from a chair causing the hip to dislocate.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
An act artic e1 hip brg 28x38mm, was returned and evaluated against the complaint.Visual inspection found significant scratching near the apex of the bearing with lighter scratching around the radius.Clusters of pits were also sporadically observed around the outer radius.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) mmi review: initial normal postoperative appearance of right total hip arthroplasty with follow-up image demonstrating dislocation of the femoral component superolaterally with respect to the acetabular cup.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ACT ARTIC E1 HIP BRG 28X38MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11761270
• Report Number: 0001825034-2021-01334
• Device Sequence Number: 3142122
• Product Code: LPH
• UDI-Device Identifier: 00880304485020
• UDI-Public: (01)00880304485020(17)250210(10)578620
• 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,Followup
• Report Date (Section B): 05/11/2021

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: 02/10/2025
• Device Model Number: N/A
• Device Catalogue Number: EP-200144
• Device Lot Number: 578620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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 Weight: 84