MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PATELLA; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona femur cemented posterior stabilized (ps) catalog # 42500006202 lot # 62034136.Persona natural tibia cemented catalog # 42532006702 lot # 63331185.Persona articular surface fixed bearing posterior stabilized (ps) catalog # 42522400511 lot # 62308346.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted.Multiple mdr reports were filled for this event: 3007963827-2020-00141, 0001822565-2020-01765, 0001822565-2020-01766.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experiencing moderate pain, increased instability, and a mild effusion.No intervention or revision has been reported to date.Attempt for further information has been made, but no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical records review indicates that at 1-year patient had moderate instability, pain and x-ray findings of 3.6mm radiolucency of the posterior condyle.At 2-year follow-up severe instability, rom 110 degree, moderate pain, mild effusion and x-rays findings of 3.0mm tibial radiolucency.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 ALL POLY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10082677
• Report Number: 0002648920-2020-00272
• Device Sequence Number: 16853047
• Product Code: JWH
• UDI-Device Identifier: 00889024247642
• UDI-Public: (01)00889024247642
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42540000035
• Device Lot Number: 63463168
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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: Other
• Patient Weight: 97