MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW RIGHT SIZE 3; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2020-00061; 3007963827-2020-00062.Concomitant medical product: tibia cemented 5 degree stemmed right, item# 42532006402, lot# 63846697; articular surface fixed bearing cruciate retaining (cr) right, item# 42522000410, lot# 64093156.Report source: (b)(6).Customer has indicated that the product will not be 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 one year and two months¿ post implantation due to pain and stiffness.Surgeon stated the implant appeared well aligned but oversized patella baja was noted.There is no additional information at this time.
Additional Manufacturer Narrative
No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patella baja is defined by the insall-salvati ratio (patellar tendon length-length of the posterior surface of the tendon from the lower pole of the patella to its insertion on the tibial tubercle) divided by (patellar length-greatest pole-topole length).In this provided image, the ratio measures 0.817.Patella baja occurs when the ratio measures less than 0.8, indicating borderline patella baja.Overall fit and alignment of the implants, as well as bone quality, appear normal.One-page clinic note is for initial surgical planning and scheduling.No other information was provided.Patella baja was confirmed however, pain and stiffness issues cannot be confirmed.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.Per package insert 87-6204-022-23 persona the personalized knee system: pain is known adverse effect of the system.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 RIGHT SIZE 3
• 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: 9768956
• Report Number: 3007963827-2020-00060
• Device Sequence Number: 2185770
• Product Code: JWH
• UDI-Device Identifier: 00889024229846
• UDI-Public: (01)00889024229846
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 42502005402
• Device Lot Number: 63405040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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: 55