MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X46MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	05/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item number 650-1065 item name cer option type 1 tprsleve -3 lot # 3031054.Item number 650-1055 item name cer bioloxd option hd28mm lot # 3050662.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that patient underwent total hip total hip arthroplasty.Subsequently, sales rep was called in for a total hip dislocation the same day.Upon opening the patient it was discovered that the head had disassociated from the bearing.It was decided to revise the head and bearing.At this time what appeared to be poly shavings were inside the bearing and the bearing was deformed and scratched inside and out.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 information.The following sections were updated/corrected updated: a2; a4; b5; b7; d6; g3; h2; h3; h6 d10: item number 650-1065 item name cer option type 1 tprsleve -3 lot # 3031054 item number 650-1055 item name cer bioloxd option hd28mm lot # 3050662 item number unk item name unk shell lot # unk item number unk item name unk taperloc stem lot # unk product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported primary right tha was placed.Subsequently patient experienced pain, and elevated metal ions, and underwent right tha revision of head to dual mobility ceramic inner head and poly e1 outer bearing approximately ten (10) years post implantation.Additionally eleven (11) days after the first revision patient underwent orif/revision due to right tha dislocation and was found disassociation of dual mobility components, with implant wear, debris and small amount of metallosis was noted.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 information.Corrected: d6 implant date.   one act artic e1 hip brg 28x46mm item# ep-200152 lot# 668880 was returned and evaluated.Upon visual inspection the returned bearing had been deformed and there were indentations around the od.There was a taper also retuned that had debris and a wear line visible.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.A review of the available records identified: extensive wear of the bearing, attempted closed reduction, i&d of plastic debris, popping sensation that progressed to dislocation as reported, and difficulty ambulating.A small amount of metallosis was noted.No complications were noted during the procedure.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 28X46MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12173904
• Report Number: 0001825034-2021-02111
• Device Sequence Number: 10984745
• Product Code: LPH
• UDI-Device Identifier: 00880304485068
• UDI-Public: (01)00880304485068(17)240829(10)668880
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161190
• 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,Followup
• Report Date (Section B): 10/14/2021

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: 08/29/2024
• Device Model Number: N/A
• Device Catalogue Number: EP-200152
• Device Lot Number: 668880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 10/14/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/20/2021; 10/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 64