MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) NARROW POROUS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona articular surface medial congruent (mc) right 10 mm catalog 42522100110 lot 63753017, nexgen complete knee solution, trabecular metal patella catalog 00587806532 lot 64176468, natural tibia trabecular metal fixed bearing right size d catalog 42530006702 lot 62869826.The product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04181, 0001822565-2019-04182.
Event or Problem Description
A patient enrolled in a clinical study underwent right knee arthroplasty and was noted to have stiffness and decreased range of motion during their one month follow-up visit.Patient underwent a manipulation under anesthesia approximately two weeks later.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
A patient enrolled in a clinical study underwent right knee arthroplasty and was noted to have stiffness and decreased range of motion during their one month follow-up visit.Patient underwent a manipulation under anesthesia approximately two weeks later and again approximately one month later.Patient continues to have pain and stiffness as of the three month follow up.
Event or Problem Description
No additional information reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of the available records by a health care professional noted the patient experienced stiffness requiring manipulation under anesthesia.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) NARROW POROUS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9135002
• Report Number: 0001822565-2019-04182
• Device Sequence Number: 14249567
• Product Code: MBH
• UDI-Device Identifier: 00889024470101
• UDI-Public: (01)00889024470101
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2020

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: 42502206402
• Device Lot Number: 64071413
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 02/27/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 01/06/2020; 03/02/2020
• 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: Required Intervention
• Patient Weight: 69