MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E; PROSTHESIS, KNEE

Model Number 42-5320-071-01

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

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 12/24/2019

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial left total knee arthroplasty without complications.Subsequently, the patient has reported ongoing pain, swelling, and popping in the knee for the past two years and four months since implantation.Additionally, the patient is having range of motion issues with one knee and cannot bend or kneel.The patient has had bilateral knee replacements and it is unknown which knee is having range of motion complications.No medical intervention has been reported at the time of this report.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: femur cemented cruciate retaining (cr) standard left size 7: catalog# 42502606201, lot#6 4228083; articular surface fixed bearing ultra congruent (uc) left 14 mm height: catalog# 42512200514, lot# 64279930; all-poly patella cemented 32 mm diameter; catalog# 42540200032, lot# 64540883; refobacin bc r 1x40 us: catalog# 110034355, lot# 818eak2709, qty#2.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00136; 3007963827-2022-00138; 0002648920-2022-00124.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified no complication during the initial surgery.No further records were provided for ongoing reported issue.Root cause was unable to be determined.Per package insert, pain, poor range of motion, and swelling are known adverse effects of the 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.

Event Description

No further event information at time of this report.

• Brand Name: NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14437590
• MDR Text Key: 292046959
• Report Number: 3007963827-2022-00137
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471054
• UDI-Public: (01)00889024471054(17)290930(10)64417330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 42-5320-071-01
• Device Catalogue Number: 42532007101
• Device Lot Number: 64417330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male