MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: associated products : item#:42532006102; tibia cemented 5 degree stemmed right size b lot#:63315950.Item#:42540200032; all-poly patella cemented 32 mm diameter; lot#:63321031.Item#:42522200510; articular surface (uc) right 10 mm height; lot#:63057909.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is against hospital policy.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: 3007963827-2020-00252.
Event or Problem Description
Patient underwent an initial right knee procedure 4 years ago.Subsequently the patient was revised last month due to femoral loosening and a mal rotated tibial.
Event or Problem Description
No further event information available at the time of this report.
Additional 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 related to the reported event were found.Medical records were reviewed by a health care professional.Review of the available records identified the following: pre/post diagnosis : broken internal right knee prosthesis (please note implant fracture not identified within op records, however loosening due to the implant coming off the cement interface the implant loosened).Patient had a loose femur that came off at the bone cement interface.No signs of infection.Lost some bone posterior medially that was caught between the little peg of the femur and distal to posterior.The art surface was removed and the tibial tray was internally rotated.Mal-tracking of the patellar component preoperatively 6 degree offset tibia, some bone loss from where catheter was but not much.Trialed a metaphyseal cone; however it would not fit the offset.Reamed to 13 on femur and made a 6 degree valgus cut off of that, and 5mm distally on the lateral side, that cut 10mm on medial side in order to tighten up the extension gap 40mm constrained poly placed gave good stability mid flexion and flexion / extension.The medial collateral ligament was a little loose which is the purpose of the constrained poly.No complications reported during surgery.A definitive root cause cannot be determined.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 7
• 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: 10636132
• Report Number: 3007963827-2020-00251
• Device Sequence Number: 2439365
• Product Code: JWH
• UDI-Device Identifier: 00889024230361
• UDI-Public: (01)00889024230361
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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 Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 42502606202
• Device Lot Number: 63221546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 98