MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00587806535, patella, lot # 63538625, 00588605712, tibial component, lot # 62047573.
Event or Problem Description
It was reported that approximately 2 years post implantation, the patient was revised due to pain, stiffness, instability, limited rom, and swelling.X-rays noted tibial cut was in significant varus.During the revision procedure, heterotopic ossification, poly wear, and loosening of the femoral component were noted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Visit notes demonstrated that the patient started to feel pain and swelling due to too much golf.Approximately 4 months later, heterotopic bone was noted along the medial margin of the distal femoral diaphysis and within the suprapatellarregion.Four months later, the patient fell and experienced pain and swelling.Office visit notes demonstrated that the patient had antalgic gait for left leg.X-ray review of the tibial component appears to be in varus, and the surgeon notes that tibial cut is in significant varus.Additional visit notes demonstrated worsening left knee pain, increasingly antalgic gait with progressive loss of motion and increasing joint stiffness, effusion noted, rom 0-115 degrees, laxity, and plan for revision l tka.Revision op notes demonstrated that the patient was revised due to pain.During revision, patella was found wear, femoral was loose.Heterotopic bone removed.All zimmer biomet implants were revised.Competitor¿s implants implanted.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: FEMUR TRABECULAR METAL POSTERIOR STABILIZED (PS) STANDARD POROUS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9238248
• Report Number: 0001822565-2019-04617
• Device Sequence Number: 13855837
• Product Code: MBH
• UDI-Device Identifier: 00889024469938
• UDI-Public: (01)00889024469938
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42500806801
• Device Lot Number: 63597279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 03/10/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 102