MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA POSTERIOR STABILIZED FIXED BEARING ARTICULAR SURFACE LEFT 13MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that the patient underwent an aspiration, arthrocentesis and triamcinolone acetonide injections to address pain, synovitis, loss of range of motion, joint effusion and swelling approximately six months following left knee arthroplasty.Initial operative notes noted no intraoperative complications.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - persona revision cemented standard femoral component left size 7 catalog #: 42504606201 lot #: 64890357, persona revision straight splined uncemented stem extension 14mm x +135mm catalog #: 42560113514 lot #: 64847681, persona revision cemented tibial component left size g catalog #: 42542007901 lot #: 64817981, persona revision offset splined uncemented stem extension 3mm x 10mm x +135mm catalog #: 42560313510 lot #: 64783515, biomet bone cement r 1x40 us catalog #: 110035368 lot #: ay09ac0107.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 0001822565-2024-00865, 0001822565-2024-00866, 0001822565-2024-00867, 0001822565-2024-00868, h3 other text : investigation incomplete.

• Brand Name: PERSONA POSTERIOR STABILIZED FIXED BEARING ARTICULAR SURFACE LEFT 13MM
• Type of Device: 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: 18901928
• MDR Text Key: 337628144
• Report Number: 3007963827-2024-00069
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024237438
• UDI-Public: (01)00889024237438(17)240630(10)64355165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512400913
• Device Lot Number: 64355165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White