MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL KNEE CEMENTED TIBIAL COMPONENT SIZE F RIGHT MEDIAL; 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); Numbness (2415)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review (reference (b)(4) in order to identify potential adverse trends.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: onset findings: pt seen in clinic reporting significant discomfort to medial aspect of r knee.Ct scan showed increased activity under tibial plate and remodeling from clear evidence of overload.Patient seen in clinic approximately 8 months from previous visit reporting continued medial pain and numbness to lateral side of study knee.X-rays show no significant changes.Pt advised to continue with weight reduction.Currently at (b)(6) kg.The complaint cannot be confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Additional associated products and mdrs: 42558000502 persona partial knee cemented femoral component size lot# 63856205.Mdr- 0001825034-2020-04345.42528200609 persona partial articular surface right medial size f 9mm lot# 63449781.Mdr- 0001825034-2020-03456.
Event or Problem Description
It is reported that a patient experienced significant discomfort and numbness in the medial aspect of the knee nineteen (19) months following right knee arthroplasty.A the patient was advised to continue reducing weight and no medical intervention was performed.Attempts have been made for additional information, however, no additional information is available at this time.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED TIBIAL COMPONENT SIZE F RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10987640
• Report Number: 0001825034-2020-04346
• Device Sequence Number: 10935353
• Product Code: HSX
• UDI-Device Identifier: 00880304812710
• UDI-Public: (01)00880304812710
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000602
• Device Lot Number: 63886720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/10/2020
• 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: 151