MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994); Synovitis (2094); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent initial right total knee arthroplasty approximately 8 months ago.Subsequently the patient was revised last month due to pain, joint effusion with synovitis, popliteal cyst and aseptic loosening.During the procedure it was discovered loosening occurred at the bone cement interface.All metal components removed related to sensitivity to nickel, patella remained intact.No complications.
Additional Manufacturer Narrative
(b)(4).Associated products : item#:42532007502 tibia cemented 5 degree stemmed right size f lot#: 64830490.Item#: 42522600812; articular surface fixed bearing (cps) right 12 mm; lot#: 64167490.Item#: 42540200035; all-poly patella cemented 35 mm diameter; lot#: 64833138.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2022 -00018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies related to the event during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for these items and the reported part and lot combinations medical records were provided and reviewed by a health care professional.Review of the available records identified the following: office visit: pain with activities and at night, minimal swelling; revision notes: tibial component loose, no fractures or evidence of infection.Preoperative testing revealed mild reaction to nickel.Complaint is confirmed.The root cause of the allergic reaction is attributed to patient condition.However, the tibial component does not contain nickel, for the components reported issues, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) NARROW RIGHT SIZE 10
• 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): .; 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: 13255959
• Report Number: 3007963827-2022-00019
• Device Sequence Number: 11910567
• Product Code: JWH
• UDI-Device Identifier: 00889024228825
• UDI-Public: (01)00889024228825(17)301026(10)64912973
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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: 42500006802
• Device Lot Number: 64912973
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: Female
• Patient Weight: 109 KG