MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT 360 TIBIAL TRAY 75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	12/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It is reported that the patient underwent revision right total knee arthroplasty.Subsequently, patient underwent a revision procedure approximately 8 months post-implantation due to pain and a protrusion of the medial knee which was identified as the locking bar that backed out.The locking bar was replaced without complication.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: item 185224 lot 097360 item 185343 lot 175490 item 185263 lot 6214793 the complaint is confirmed.Visual examination of the returned product identified signs of wear and gouges.Device was submitted for further analysis.Analysis states that even though the examined locking bar contact mark and deformation observations are consistent with the bars not being fully engaged with the tibial tray lugs, it cannot be determined with certainty whether the reported locking bar dissociations occurred due to improper insertions.A more definitive conclusion would require analysis of not just the locking bars, but also of the mating tibial trays as well as the implanted bearings.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no obvious wear, stable, locking bar backed out when in flexed position, locking bar replaced, no complications.Ebl 70ml.Mmi report confirms backed out locking bar.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the arthroplasty components are anatomically aligned without fracture or dislocation.The locking bar of the tibial implant has retracted and is displaced medially.Bone quality appears osteopenic.There is no evidence of loosening, wear, or abnormal radiolucency and alignment is maintained.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.

• Brand Name: BMT 360 TIBIAL TRAY 75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11156394
• Report Number: 0001825034-2021-00038
• Device Sequence Number: 2564481
• Product Code: JWH
• UDI-Device Identifier: 00880304481435
• UDI-Public: (01)00880304481435(17)260407(10)321200
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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 Expiration Date: 04/07/2026
• Device Model Number: N/A
• Device Catalogue Number: 185204
• Device Lot Number: 321200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/16/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 60