MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10 MM HEIGHT; 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); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Associated products : item#: 42500606602; femur cemented (ps) standard right size 9; lot#: 64587520; item#: 42532007502; tibia cemented 5 degree stemmed right size f; lot#: 64693145; item#: 42540200038; all-poly patella cemented 38 mm diameter; lot#: 64765394; item#: 42509902525; 2.5 mm female hex screw 25 mm length; lot#: 64744234; item#: 00579104100; 48mm headed screw; lot#: 64810230; item#: 00579104100; 48mm headed screw; lot#: 64810234.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: office visit (b)(6) 2021: pain continues with activities (6/10); mri shows mild thickening/edema on it band, nonspecific effusion, alignment is good; revision (b)(6) 2021: poly found with no wear or signs of impingement, it band palpated and transected, femoral component in correct position; femur, tibia and patellar well fixed; no complications.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
It was reported the patient underwent an initial right total knee arthroplasty approximately 13 months ago.Subsequently, the patient was revised on 12 months later due to persistent pain for one year.During the procedure there was some mid flexion laxity which the it band was transected.The poly was exchanged without difficulty.

• Brand Name: ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12799648
• Report Number: 3007963827-2021-00286
• Device Sequence Number: 17572466
• Product Code: MBH
• UDI-Device Identifier: 00889024243750
• UDI-Public: (01)00889024243750(17)250228(10)64566166
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522400710
• Device Lot Number: 64566166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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; Hospitalization
• Patient Sex: Male
• Patient Weight: 84 KG