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

Catalog Number	42522400710
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10: medical product: femur cemented posterior stabilized (ps) standard right size 9: catalog#42500606602, lot#65641957; tibia cemented 5 degree stemmed right size f: catalog#42532007502, lot#65780988; all-poly patella cemented 35 mm diameter: catalog#42540200035, lot#65960799.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, ten (10) months post-implantation, the patient presented with pain, numbness, swelling, clicking, and limping ambulation and underwent revision surgery.Scar tissue was debrided and joint laxity was noted during the procedure.The femoral, tibial, and articular surface components were revised without complication.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The condition of the components is unknown.Device history record was reviewed and no discrepancies related to the reported event were found.Primary operative notes state there were no intra operative complications.Post initial surgery office notes state patient was experiencing pain, numbness, swelling, pain with activity and clicking noise.Patient is also ambulating with limp and flexion contracture was noted.Revision surgery notes state scar tissue was debrided, and all components were well fixed.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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 at time of this report.

• Brand Name: PERSONA 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19459296
• Report Number: 3007963827-2024-00210
• Device Sequence Number: 7926260
• Product Code: MBH
• UDI-Device Identifier: 00889024243750
• UDI-Public: (01)00889024243750(17)280406(10)65753192
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: Lay User/Patient
• Device Catalogue Number: 42522400710
• Device Lot Number: 65753192
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 100 KG