MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET TIBIAL LOCKING BAR; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event was unable to be confirmed.Medical records were provided and reviewed by a hcp, but did not note any pain or mobility issues post implantation.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.Concomitant medical products: 184508, femoral component, lot # 318040; 141314, finned pri stem, lot # 255700; 141273, tibial tray, lot # 834180; 184764, patella, lot # 470450; ep-183640, bearing, lot # 464570.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04681, 0001825034-2019-04682, 0001825034-2019-04684, 0001825034-2019-04694, 0001825034-2019-04688.
Event or Problem Description
It was reported that approximately 5 months post revision, the patient has continued to have pain and difficulty with ambulation interfering with daily life.Attempts have been made and no further information has been provided.

• Brand Name: BIOMET TIBIAL LOCKING BAR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9652496
• Report Number: 0001825034-2020-00460
• Device Sequence Number: 11454198
• Product Code: JWH
• UDI-Device Identifier: 00880304009738
• UDI-Public: (01)00880304009738
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141205
• Device Lot Number: 884630
• 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: 01/27/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other