MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional associated products & mdrs: 42500606002 femur cemented posterior stabilized std rt sz 6, lot# 65020929.Mdr: 3007963827-2023-00296.42532007102 tibia cemented 5 degree stemmed rt size e, lot# 65046976.Mdr: 3007963827-2023-00298.42540200032 all-poly patella cemented 32 mm dia, lot# 65134432.Mdr: 0002648920-2023-00263.
Event or Problem Description
It was reported a patient complained of pain, swelling, limited extension, severe limp, and chronic quadriceps weakness.The surgeon suspected a quadriceps tendon tear.Approximately one year, six months post implantation, the patient underwent a revision where significant scar tissue was encountered due to patella baja but all patella and quadriceps tendons were found intact.The femoral, tibia, and poly were revised with competitor products.The patella was not revised.The patient is alleging her components were too large.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: office visit 1: small knee effusion, painful gait with severe limp, x-ray: components in good position and alignment- no evidence of loosening; op-notes: no intra-op complications identified in partial op note provided, severe scar tissue noted with patella baja, patella and quadricep tendons were completely intact without injury.Complaint is confirmed from the provided medical records.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10MM
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18040574
• Report Number: 3007963827-2023-00297
• Device Sequence Number: 17947514
• Product Code: JWH
• UDI-Device Identifier: 00889024243750
• UDI-Public: (01)00889024243750(17)260425(10)65004577
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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 Expiration Date: 04/25/2026
• Device Model Number: N/A
• Device Catalogue Number: 42522400710
• Device Lot Number: 65004577
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female