MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT SIZE E RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices - persona trabecular metal cruciate retaining porous femoral component catalog #: 42502806002 lot #: 63851539, persona cruciate retaining articular surface 13mm right catalog #: 42522000513 lot #: 64427566.Report source - foreign: (b)(6).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.Device evaluated by manufacturer? investigation incomplete.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision to address pain, medial tibia fracture and tibial component loosening nine (9) days post-operatively.Attempts have been made and no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated and the reported event was confirmed through review of medical records.The returned tibial plate showed signs of use and white patches could be seen on the back, suggestive of bone cement.The articular surface was still assembled to the tibial plate.The device history records were reviewed and no discrepancies were identified.Per the package insert, pain, loosening and bone fracture are known adverse effects of knee arthroplasty.However, 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 TRABECULAR METAL TWO-PEG POROUS TIBIAL COMPONENT SIZE E RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10178987
• Report Number: 0001822565-2020-02172
• Device Sequence Number: 11533795
• Product Code: MBH
• UDI-Device Identifier: 00889024510562
• UDI-Public: (01)00889024510562
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2020

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: 42530007102
• Device Lot Number: 64264744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70