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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00121.Concomitant medical devices: articular surface fixed bearing cruciate retaining (cr) left 10 mm height, catalog#: 42512000410, lot#: 63128799.Tibia cemented 5 degree stemmed left size d, catalog#: 42532006701, lot#: 63727672.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 patient underwent left knee procedure on an unknown date in (b)(6) 2019.Subsequently, the patient reports swelling, instability, and that a bone scan shows loosening.The patient tested positive for a sensitivity to nickel.No revision procedure was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: a1, b2, b3, b4, b5, b7, d7, d11, e1, e2, e3, e4, g4, g7, h2, h3, h6, and h10.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 patient underwent a revision procedure approximately two years post implantation due to ongoing pain, swelling, and instability.During the revision, the surgeon noted that the patient had extreme lateral laxity.A broken tibial screw was noted and removed.All components were exchanged for competitor product.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g4, g7, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication was noted during the initial surgery.6-month after post ops, the patient's tendon started catching the implant and experiencing swelling, 90 degrees locked angle, so the patient underwent mua and cleaned up the scar tissue.Day after manipulation, the tendon caught again, and they went in and released the tendon and replaced the bearing with a more stabilizing one.After the poly exchange, the patient reported that she experienced swelling and buckling; the bone scan shows loosening.Patient also mentioned she has metal allergies.So the patient underwent surgery for pain and instability.At the time patient was informed that she had lateral laxity.Still, we were unable to revise the tibia component secondary to a bent tibial screw.Patient noted to be extremely lax laterally, all components removed without complication, broken screw identified, and removed from the medullary canal.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 6
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 9988310
• Report Number: 3007963827-2020-00120
• Device Sequence Number: 17117743
• Product Code: JWH
• UDI-Device Identifier: 00889024229891
• UDI-Public: (01)00889024229891(17)271130(10)63878209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2020

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: 42502006001
• Device Lot Number: 63878209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/26/2020; 08/13/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/22/2020; 08/17/2020
• 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; Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 61