MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ B HI 60MM; PROSTHESIS HIP

Catalog Number	11-301312
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part # unknown / unknown stem/ lot # unknown; part #unknown / unknown head/ lot # unknown; part #unknown / unknown liner/ lot # unknown; part #unknown / unknown screw/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00605.
Event or Problem Description
It was reported that patient was revised one-year post implantation due to a fall causing dislocation.During the revision it was discovered the taper junction between the arocs cone body and stem was not engaged.However, the set screw was found to be in place.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.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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: ARCOS CON SZ B HI 60MM
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11420823
• Report Number: 0001825034-2021-00604
• Device Sequence Number: 17270829
• Product Code: MAY
• UDI-Device Identifier: 00880304474093
• UDI-Public: (01)00880304474093(17)030212(01)267450
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 07/16/2021

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 Catalogue Number: 11-301312
• Device Lot Number: 267450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention