MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS); 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); Scar Tissue (2060)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event was initially reported under the incorrect mfr number (0001822565-2024-00005).D10 - medical product: standard primary patella catalog # 00587806532 lot # 64227886; bone cement catalog # unk lot # e2703z20ca; bone cement catalog # unk lot # 005eae2407; bone cement catalog # unk lot # f2702z12ca; stem extension catalog # unk lot # 64859495; femur catalog # unk lot # 64867254 ; tibia e catalog # unk lot # 64804179; tibial cone xs catalog # unk lot # 64815920; stem extension catalog # unk lot # 64925236; lateral tibial augment catalog # unk lot # 64826750; medial tibial augment catalog # unk lot # 64817484; art surface cps 12mm catalog # unk lot # 64214783; cancellous bone graft catalog # unk lot # unk.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient had pain and popping of the patella one year post implantation.The patient underwent revision of the poly articular surface, during which, abundant scar tissue was debrided from the patella.The patient was placed on an oral steroid dose pack due to history of chronic arthrofibrosis.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h4, h6, h11 reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that patient presented with pain with catching popping of the patella and abundant scar tissue about the superior and inferior aspect of the patella; knee stability was excellent in extension with some gapping in flexion.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: PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS)
• 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: 19360779
• Report Number: 3007963827-2024-00190
• Device Sequence Number: 20436987
• Product Code: MBH
• UDI-Device Identifier: 00889024244580
• UDI-Public: (01)00889024244580(17)240229(10)64214783
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522600712
• Device Lot Number: 64214783
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female