MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi : (b)(4).Concomitant medical products: item#: 189080; vngd ant stblzd brg 10x75; lot#: 290170, item#: 183033; vanguard cr ilok fem-lt 72.5; lot# :j6725460, item#: 184792; series a asymmetric pat 31x8; lot#: 416530.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been retained by the hospital for analysis.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Patient underwent original left tka on six months ago.Subsequently patient underwent a revision last month as the locking bar backed out, due to a fall when the patient passed out while working in his garage on 12 days post initial tka.The surgeon believes the patient fell perfectly to impact his poly in the exact spot to disengage the locking bar.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision to left knee removal of locking pin and poly exchange with washout, pain, notes images post fall shows locking bar migration, presented with pain and tenting of skin due to locking bar, found locking bar completely out of tibia and into soft tissue, removed locking bar and poly, both tibia and femur components found stable, no complications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit and alignment appears normal on the earlier time point images.However, on the latest time point image, there is backing out of the medial tibial bar.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET CC CRUCIATE TRAY 75MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10900553
• Report Number: 0001825034-2020-04220
• Device Sequence Number: 11096773
• Product Code: JWH
• UDI-Device Identifier: 00887868247972
• UDI-Public: (01)00887868247972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• 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): 01/28/2021

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: 141234
• Device Lot Number: J6749169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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
• Patient Age: 79 YR
• Patient Weight: 75