MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: tibial augment cemented half block left medial size cd 5 mm thickness catalog # 42555803305 lot # 65042326; stem extension straight splined uncemented 14 mm diameter +135 mm length catalog # 42560113514 lot # 65003610; femur cemented standard left size 7 catalog # 42504606201 lot # 65046029; femoral distal augment cemented size 7, 7+ 10 mm thickness catalog # 42556606210 lot # 65003394; femoral posterior augment cemented size 7, 7+ 10 mm thickness catalog # 42556806210 lot # 65102601; femoral distal augment cemented size 7, 7+ 10 mm thickness catalog # 42556606210 lot # 65076842; tibia fixed cemented left size d stem extension use required catalog # 42542006701 lot # 65488527; tibial augment cemented half block left lateral size cd 5 mm thickness catalog # 42555803105 lot # 65003438; stem extension straight splined uncemented 16 mm diameter +135 mm length catalog # 42560113516 lot # 64911526; all-poly patella cemented 35 mm diameter catalog # 42540200035 lot # 66296662; copal g + c bone cement x2 catalog # 66041214 lot # 66541282; allovance crunch allograft catalog # unk lot # unk.G2: australia.H3: customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient dislocated due to deep flexion, three weeks post implantation.Articular surface prosthesis was revised to a more constrained liner to correct instability.No more information 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, h6, h11.Reported event was unable to be confirmed due to limited information received from the customer.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.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 POSTERIOR STABILIZED (PS)
• 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: 19744330
• Report Number: 3007963827-2024-00272
• Device Sequence Number: 12760233
• Product Code: MBH
• UDI-Device Identifier: 00889024237117
• UDI-Public: (01)00889024237117(17)251219(10)64666640
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 12/19/2025
• Device Model Number: N/A
• Device Catalogue Number: 42512400513
• Device Lot Number: 64666640
• 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: 06/23/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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
• 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
• Patient Weight: 58 KG