MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 6; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi : (b)(4).Concomitant medical products: associated products : item#:42532006701;tibia cemented 5 degree stemmed left size d; lot#:63949792.Item#:42512100414;articular surface medial congruent (mc) left 14 mm ; lot#:63788567.Item#:42540000032;all poly patella cemented 32 mm ; lot#:64239743.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: 3007963827 - 2020 - 00241, 3007963827 - 2020 - 00242, 0002648920 - 2020 - 00432.

Event Description

It was reported that patient underwent left total knee arthroplasty approximately 2 years ago.Subsequently, patient experienced pain and swelling since her procedure.Patient underwent manipulation under anesthesia three months after initial procedure, where the surgeon went in and bent and broke things lose in her knee, this did not help.Patient underwent a second manipulation 2 months after her first mua, which was orthoscopicly to remove scar tissue, this did not help either and the scar tissue grew back worse than before.Patient cannot bear weight and continues to walk with a cane.Patient has undergone allergy testing and is highly reactive to nickel.

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.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified the following: patient has a known nickel allergy.The root cause of the reported issue of allergic reaction is attributed to patient condition.The adhesions/scar tissue is a procedure related complication and therefore no device failure detected.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 LEFT SIZE 6
• 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: 10586407
• MDR Text Key: 208535959
• Report Number: 3007963827-2020-00240
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024230330
• UDI-Public: (01)00889024230330
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 42502606001
• Device Lot Number: 63819910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 73