MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00597909535 ¿ patella ¿ 64613795.42502205801 ¿ femur ¿ 64488303.00587806535 ¿ nexgen patella ¿ 64452451.42512100612 ¿ articular surface ¿ 63301944.Reported event was unable to be confirmed due to limited information provided by the customer.X-rays were reviewed by a third party hcp and notes overall fit and alignment are maintained with no evidence of loosening.Bone quality is osteopenic.Dhr was reviewed and no discrepancies were found.The root cause is 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
It was reported that patient underwent a left knee revision approximately 16 months post implantation due to pain and loosening.Femur and patella remained implanted.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: NATURAL TIBIA TRABECULAR METAL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12048682
• Report Number: 0001822565-2021-01714
• Device Sequence Number: 4359738
• Product Code: MBH
• UDI-Device Identifier: 00889024510555
• UDI-Public: (01)00889024510555(17)291231(10)64517446
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• 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
• Report Date (Section B): 06/23/2021

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 Model Number: N/A
• Device Catalogue Number: 42530007101
• Device Lot Number: 64517446
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/23/2021
• 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