MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED TIBIAL AUGMENT HALF BLOCK LEFT LATERAL SIZE EF 5MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona revision cemented standard femoral component left size 7 catalog #: 42504606201 lot #: 64683452, persona revision cemented distal femoral augment size 7 10mm catalog #: 42556606210 lot #: 64508941, persona revision cemented distal femoral augment size 7 10mm catalog #: 42556606210 lot #: 64508941, persona revision fixed cemented tibial stem extension size e left catalog #: 42542007101 lot #: 64599628, persona revision cemented tibial augment half block left medial size ef 5mm catalog #: 42555805305 lot #: 64508912, persona revision constrained condylar knee articular surface left 18mm catalog #: 42512800718 lot #: 64435985.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.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: 0001822565-2022-00768, 0001822565-2022-00769, 0001822565-2022-00770, 0001822565-2022-00771, 0001822565-2022-00773, 0001822565-2022-00774.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address pain and possible loosening approximately two (2) months post-operatively.Initial operative notes noted the patient was revised due to infection and additional antibiotics were administered in the bone cement.The surgeon noted that the extra antibiotics may result in early loosening.No intraoperative complications were reported.Revision operative notes reported that the patient was being revised for pain and potential loosening.The patella was in good position and not loose, so the surgeon did not remove it to maintain bone stock at the patella.The articular surface, femoral and tibial components were removed.No notes were made on the condition of the femoral and tibial components.No intraoperative complications were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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.D10 - concomitant devices - persona revision cemented standard femoral component left size 7 catalog#: 42504606201, lot#: 64683452, persona revision cemented distal femoral augment size 7 10mm catalog#: 42556606210, lot#: 64508941, persona revision cemented distal femoral augment size 7 10mm catalog#: 42556606210, lot#: 64508941, persona revision fixed cemented tibial stem extension size e left catalog#: 42542007101, lot#: 64599628, persona revision cemented tibial augment half block left medial size ef 5mm catalog#: 42555805305, lot#: 64508912, persona revision constrained condylar knee articular surface left 18mm catalog#: 42512800718, lot#: 64435985, unknown persona revision femoral stem 15mm x 75mm catalog#: ni, lot#: ni, unknown persona revision tibial stem 14mm x 75mm catalog#: ni, lot#: ni.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2022-00768, 0001822565-2022-00769, 0001822565-2022-00770, 0001822565-2022-00771, 0001822565-2022-00772, 0001822565-2022-00773, 0001822565-2022-00774, 0001822565-2022-02073, 0001822565-2022-02074.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA REVISION CEMENTED TIBIAL AUGMENT HALF BLOCK LEFT LATERAL SIZE EF 5MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13805775
• Report Number: 0001822565-2022-00772
• Device Sequence Number: 19806281
• Product Code: JWH
• UDI-Device Identifier: 00889024557161
• UDI-Public: (01)00889024557161(17)290731(10)64453278
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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,Followup
• Report Date (Section B): 07/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42555805105
• Device Lot Number: 64453278
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 07/12/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/20/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 79 KG