MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products: item#:42540000035; all poly patella cemented 35 mm diameter; lot#:64189156.Item#:42530007902;natural tibia trabecular metal two-peg porous fixed bearing right size g; lot#:63905801.Item#:42522100912; articular surface medial congruent (mc) right 12 mm height use with tibia sizes g-h/cr femur sizes 8-11; lot#:64167122.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still 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 event, please see associated reports: 0002648920-2020-00175.

Event Description

It was reported that the patient underwent an initial total right knee arthroplasty and subsequently, he experienced right knee patellar clunk and received an intraarticular corticosteroid injection approximately one year later.

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.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the available records identified the following: no inter-ops complication during the initial surgery.Crf review found patient was experiencing patella clunk and pain.The patient was administered with corticosteroid injection in the joint.A definitive root cause cannot be determined.Per package insert, persona the personalized knee system: pain is known adverse effect of this system.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 8
• 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: 9834867
• MDR Text Key: 183502971
• Report Number: 3007963827-2020-00080
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024230385
• UDI-Public: (01)00889024230385
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502606402
• Device Lot Number: 63964229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2020
• 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: 89