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 Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 192411 echo por fmrl red nc 11x135mm 700340.010000645 g7 pps solid acet shell 56f 6361060.110024464 g7 dual mobility liner 44mm f lot: unknown.163662 28mm mod hd std neck tp1 taper 573190.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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 - 02476 liner.0001825034 - 2020 - 02477 head.
Event or Problem Description
It was reported that a patient underwent bilateral dual mobility hip replacement.The patient fell in the shower sixteen days later and dislocated the right hip, dual mobility head and bearing still intact.Upon reduction in the er, the bearing came disassociated from the head.The 28 mm head was still on the stem and was reduced into the g7 cup, but the dm poly bearing was floating loosely in the capsule.The patient had revision surgery twenty days after the initial surgery.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).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d10, d11, g4, h2, h3, h6.Reported event was confirmed by review of radiographs and examination of devices.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.One act artic hd arcom xl 28x44mm and one g7 dual mobility liner 44mm f were returned and evaluated.Upon visual inspection the head is installed inside of the liner.The head moves freely inside of the liner.Due to the head and liner being assembled no further measurements were taken.Radiographs were reviewed by a health care professional and identified the following: right total hip arthroplasty with superior dislocation of the right femoral head, possibly related to undersized femoral head component.Prominent appearance of the acetabular cup secondary to significant cement thickness.Radiolucency at the bone cement interface of the acetabular cup suggests possible loosening of the cement.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: 10188255
• Report Number: 0001825034-2020-02474
• Device Sequence Number: 16898208
• 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): 10/07/2020

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: 12/11/2024
• Device Model Number: N/A
• Device Catalogue Number: XL-200150
• Device Lot Number: 048610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 10/07/2020
• 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 LOT: 373030.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention