MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET COCR I-BEAM TRAY 83MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-00134.The locking bar of the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during right total knee arthroplasty the locking clip was difficult to insert through the tibial insert and tibial tray.A second tibial insert and locking clip were used to complete the procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The tibial tray remains implanted, but the locking bar was returned.Visual examination of the returned product identified wear marks and nicks/dings on the locking bar.Device was submitted for further analysis.Analysis determined smearing on the leading edge of the locking bar.No significant contact marks or smearing was observed on the underside of the device or on the clasp tip and underside and contact marks near the insertion dimple of the device.Device history record was reviewed and no discrepancies relevant to the reported event 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: BIOMET COCR I-BEAM TRAY 83MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11494666
• Report Number: 0001825034-2021-00770
• Device Sequence Number: 16888883
• Product Code: JWH
• UDI-Device Identifier: 00887868247903
• UDI-Public: (01)00887868247903(17)300720(10)J6823717
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141226
• Device Lot Number: J6823717
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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
• Patient Age: 50 YR
• Patient Weight: 109