MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED HALF BLOCK TIBIAL AUGMENT LEFT MEDIAL SIZE CD 15MM; 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); Swelling/ Edema (4577)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was treated with an injection for pes bursitis approximately seventeen (17) months following a left knee arthroplasty to address continuous post-operative pain and swelling.The patient's pain resolved after the injection was administered, however, the patient continued to have worsening moderate effusion.Initial operative notes noted that the partial knee arthroplasty tracked without complication and the patient's range of motion was zero (0) to one-hundred forty(140) degrees and stable.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
B)(4).Concomitant medical products: medical devices: persona revision cemented plus femoral component left size 5+ catalog #: 42504605811; lot #: 64675747, persona revision fixed bearing articular surface left 24mm catalog #: 42512800424; lot #: 64559466, persona revision cemented tibial component left size c catalog #: 42542006401; lot #: 64334614, persona revision cemented distal femoral augment size 5 catalog #: 42556605805; lot #: 64624148, persona revision cemented half block tibial augment left lateral size cd 15mm catalog #: 42555803115; lot #: 64648336.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: 0001822565-2022-01561, 0001822565-2022-01562, 0001822565-2022-01563, 0001822565-2022-01564, 0001822565-2022-01565.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.Medical records provided confirmed the patient had mild pes bursitis and received an injection, which resolved the pain.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 REVISION CEMENTED HALF BLOCK TIBIAL AUGMENT LEFT MEDIAL SIZE CD 15MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14517038
• Report Number: 0001822565-2022-01566
• Device Sequence Number: 6531251
• Product Code: JWH
• UDI-Device Identifier: 00889024557512
• UDI-Public: (01)00889024557512(17)300228(10)64661641
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/18/2022

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 Model Number: N/A
• Device Catalogue Number: 42555803315
• Device Lot Number: 64661641
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 67 KG