MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: femur trabecular metal, item# 42502806601, lot# 64592715.Tibial augment cemented half block left lateral size ef 15 mm thickness, item# 42555805115, lot# 64628774.Tibial augment cemented half block left medial size ef 15 mm thickness, item# 42555805315, lot# 64630424.Stem extension tapered cemented 14 mm diameter +75 mm, item# 42560007514, lot# 64875941.Femur cemented standard left size 9, item# 42504606601, lot# 64890454.Stem extension tapered cemented 14 mm diameter +75 mm length, item# 42560007514, lot# 65047301.2.5 mm female hex screw 25 mm length, item# 42509902525, lot# 65130228.Hex headed screw 3.5 mm hex 48 mm length, item# 00590103548, lot# 64797688.Hex headed screw 3.5 mm hex 27 mm, item# 00590103527, lot# 64768589.Headless trocar drill pin 3.2 mm diameter 75 mm length, item# 00590102000, lot# 65019755.The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient was revised approximately three months¿ post implantation due to subsidence.The tibia subsided and shifted medially.Patient stated he "felt something" while doing physical therapy rehab.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted such as wear/discoloration and foreign material and the articular surface assembled to it.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: findings suggest loosening.Secondary to loosening, there is separation of the lateral tibial plate with respect to the lateral tibial plateau.This creates a gap between the hardware and bone.Questionable additional periprosthetic lucency without bone and hardware separation at the level of the medial tibial peg.Alignment otherwise appears normal.No additional findings of wear.Subsidence could be present but cannot be confirmed with a single time point.There is separation between the hardware and bone which is likely a new finding and likely related to subsidence, which would require prior time point to confirm (as subsidence is defined as movement of hardware over two separate time points).Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12287906
• Report Number: 0001822565-2021-02178
• Device Sequence Number: 11671362
• Product Code: MBH
• UDI-Device Identifier: 00889024510555
• UDI-Public: (01)00889024510555(17)301220(10)64649464
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007101
• Device Lot Number: 64649464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention