MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Associated products : item#: 42532006401; tibia cemented 5 degree stemmed left size c; lot#: 64550172, item#: 42512100311; articular surface medial congruent (mc) left 11 mm; lot#: 63819065,and item#: 42540000026; inset all poly patella; lot#: 64589991.Multiple mdr reports were filed for this event, please see associated reports: (b)(4).
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty 14 months ago.Subsequently, patient had no issues immediate post op but started to experience swelling and stiffness/tightness shortly after.Patient had difficulty walking, standing, getting up and down from sitting position.Patient was able to walk up to one mile.Patient underwent an aspiration to remove fluid approximately 6 months ago and got no relief.Approximately 3 months ago symptoms started to get worse; patient was now experiencing pain and can't stand for more than 10 min, can't get up and down, can't bend knee, can't walk any distance without pain.Patient underwent second aspiration last month and fluid was sent for testing for infection.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information: an additional medwatch report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the patient believes she was experiencing allergic reactions, in addition to the prior reported symptoms, and was seeing an allergist.Attempts for additional information have been made.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Once the investigation has been completed, an additional follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty.Subsequently, patient had no issues immediate post op but started to experience swelling and stiffness/tightness shortly after.Patient had difficulty walking, standing, getting up and down from sitting position.Patient was able to walk up to one mile.Patient underwent an aspiration to remove fluid approximately 7 months post procedure and got no relief.Approximately 4 months later things started to get worse; patient was now experiencing pain.Can't stand for more than 10 min, can't get up and down, can't bend knee, can't walk any distance without pain.Patient underwent second aspiration 5 months later and fluid was sent for testing for infection.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and supply corrections to h6 codes referenced.Root cause remains unchanged.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial surgery notes: rom adequate stability, no complications; completed physical therapy.2nd visit notes: arom flexion of 120 degrees, prom 130 degrees.Mobility and strength improved.Some tightness over the knee has disrupted sleep however patient did 'very well in physical therapy' 3rd visit notes: lab results cbc normal, positive for mild-moderate warmth swelling and mild recurrent effusion, rom 0-12 degrees.4th visit notes: pain worse then prior to surgery, worse with weightbearing, can walk 2-3 miles with cane, 2-3 blocks without cane.1 year follow up: continues with warmth swelling rom 0-115 degrees, x-rays show no loosening or subsidence, aspiration obtained, results normal.Complaint is confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 13337713
• Report Number: 3007963827-2022-00026
• Device Sequence Number: 19813172
• Product Code: MBH
• UDI-Device Identifier: 00889024229877
• UDI-Public: (01)00889024229877(17)290630(10)64439111
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/17/2022

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: 42502005801
• Device Lot Number: 64439111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/21/2022; 02/03/2022; 05/17/2022; 06/17/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/01/2022; 02/11/2022; 05/27/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Other
• Patient Sex: Female
• Patient Weight: 70 KG