MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REVISION CEMENTED HALF BLOCK TIBIAL AUGMENT LEFT LATERAL SIZE CD 16MM; 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); Osteopenia/ Osteoporosis (2651)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona revision fixed cemented tibial component left size c catalog #: 42542006401 lot #: 64334614, persona revision cemented half block tibial augment left medial size cd 15mm catalog #: 42555803315 lot #: 64661641, persona revision cemented femoral component plus left size 5+ catalog #: 42504605811 lot #: 64675747, persona revision fixed bearing articular surface left 24mm catalog #: 42512800424 lot #: 64559466, persona revision distal cemented femoral augment size 5 catalog #: 42556605805 lot #: 64624148.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the devices remain implanted.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: 0001822565-2022-01735 and 0001822565-2022-01737.
Event or Problem Description
It was reported that the patient is experiencing potential tibial loosening approximately two (2) years following left knee arthroplasty.No adverse effects or medical intervention has been reported at this time.Attempts have been made, however, no additional information is available.
Event or Problem Description
It was reported that the patient is experiencing pain, osteopenia and potential tibial loosening approximately two (2) years following left knee arthroplasty.A knee immobilizer was recommended temporarily for treatment.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b2, b3, b4, b5, b6, g3, g6, h1, h2, h6, h10.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records provided were reviewed and the reported tibial loosening was confirmed.The device history records were reviewed and no discrepancies relevant to the reported event 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA REVISION CEMENTED HALF BLOCK TIBIAL AUGMENT LEFT LATERAL SIZE CD 16MM
• 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: 14653889
• Report Number: 0001822565-2022-01736
• Device Sequence Number: 4904967
• Product Code: JWH
• UDI-Device Identifier: 00889024557512
• UDI-Public: (01)00889024557512(17)300131(10)64648336
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 10/04/2022

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: 42555803115
• Device Lot Number: 64648336
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 09/23/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/07/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 67 KG