MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC HD ARCOM XL 28X44MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 163662 28mm mod head 753660.010000665 g7 pps ltd acet shell 6361060.110024464 g7 dual mobility liner unknown.192411 echo por fmrl stem 700340.Product has been received by zimmer biomet and the investigation is in process.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 - 02660 head.0001825034 - 2020 - 02665 shell.0001825034 - 2020 - 02666 liner.
Event or Problem Description
It was reported patient underwent second right hip revision just over a month post initial implantation due to dislocation.During the procedure, disassociation of the dual mobility bearing was noted, head, bearing, liner, and shell components were removed and replaced.Disassociation possibly due to at home reduction attempt.Liner separation failure caused 120 min delay in the procedure.Cup came out during surgery while trying to remove duel mobility liner.New cup was cemented in place.No additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Visual inspection of the bearing showed the rim to be dinged and scratched.Multiple variations of scratches were observed on the outer radius.Radiographs indicate that there was a superior dislocation of a right tha.Cement fixation of the acetabular cup with prominent position of the acetabular cup because of a thick cement mantle.Possible fracture of the medial wall of the acetabulum.Heterotopic ossification along the greater trochanter was noted.Off label use could have contributed to the reported event.Porous acetabular shells and femoral stems are indicated for uncemented biological fixation.The implanted shell was found to be fixed in a cement mantle.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ACT ARTIC HD ARCOM XL 28X44MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10244725
• Report Number: 0001825034-2020-02663
• Device Sequence Number: 3093311
• Product Code: LPH
• UDI-Device Identifier: 00880304491359
• UDI-Public: 00880304491359
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

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: 11/22/2024
• Device Model Number: N/A
• Device Catalogue Number: XL-200150
• Device Lot Number: 769510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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: 110024464 G7 LINER 373030; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention