MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 5 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant devices: persona partial knee cemented tibial component size f right medial catalog #: 42538000602 lot #: 63886720, persona partial articular surface right medial size f 9mm catalog #: 42528200609 lot #: 63449781.Foreign report source: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 3007963827-2020-00217.0001825034-2020-03456.

Event 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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 sop040001 and wi040015) 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 150.8kg.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.

Manufacturer Narrative

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1825034 a corrected report has been filed: mdr- 0001825034-2020-04345.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA PARTIAL KNEE CEMENTED FEMORAL COMPONENT SIZE 5 RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10502696
• MDR Text Key: 205966473
• Report Number: 3007963827-2020-00216
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000502
• Device Lot Number: 63856205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 151