MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 16MM; 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); Synovitis (2094); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Muscle/Tendon Damage (4532)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address lateral collateral ligament laxity instability, hamstring tendon rupture, pain and ambulation limitations approximately one (1) year post-operatively.During the revision procedure, the patient's tissue was identified to be damaged with inflamed synovium and a synovectomy with debridement was additionally performed.Initial operative notes noted no intraoperative complications.Revision operative notes noted the patient was revised due to instability with increased laxity on lateral throughout the arc of motion.During the procedure, tissue damage with inflamed synovium was identified.The surgeon performed extensive excisional debridement through fibrinous superficial tissue down to deep capsular tissue.The tibial and femoral components were identified to be aligned and stable, but the articular surface was revised and replaced.No other intraoperative complications were identified.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona posterior stabilized cemented narrow femoral component left size 8 catalog #: 42500006401 lot #: 64983616, persona revision tapered cemented stem extension 13mm dia +75mm length catalog #: 42560007514 lot #: 65155265, persona revision cemented tibial component left size d catalog #: 42542006701 lot #: 65104608, persona revision cemented half block tibial augment left medial size cd 5mm catalog #: 42555803305 lot #: 65102646, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: az36ac0107, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: az47ba1511.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2023-00269, 0001822565-2023-02744, 0001822565-2023-02745, 0001822565-2023-02746.H3 other text : investigation incomplete.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Medical records provided confirmed ongoing pain, instability, ligament laxity, limitation of function, tissue damage and inflamed synovium.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 16MM
• 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: 17894276
• Report Number: 3007963827-2023-00268
• Device Sequence Number: 11604650
• Product Code: MBH
• UDI-Device Identifier: 00889024237964
• UDI-Public: (01)00889024237964(17)241130(10)64473342
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512600516
• Device Lot Number: 64473342
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White