MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 29 MM DIAMETER; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Joint Dislocation (2374)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products - associated products : item#:42512600412; articular surface fixed bearing (cps) left 12 mm; lot#: 64556729.Item#:42500005801; femur cemented (ps) narrow left size 5; lot#:64557779.Item#:42532006401;tibia cemented 5 degree stemmed left size c; lot#:64624295.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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00265, 3007963827-2020-00267, 3007963827-2020-00268.
Event or Problem Description
Patient was revised two days post-initial left tka due to a fall and wound dehiscence.Subluxation of the patella was noted on x-ray.Additionally, disruption of the medial collateral ligament attachment on the tibia occurred.It is unknown what caused patient to fall.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g7, h1, h2, h3, h6, and h10 it was reported that a 53-year-old female with left knee osteoarthritis underwent elective primary left total knee arthroplasty.The patient was getting up out of the bed the night of surgery and fell, subsequently hyper flexed left knee, causing subluxation of patella and disruption of prior surgical repairs.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.The patient had increased bmi of 31.37 and was hours from post tka.On post of day zero, the patient has the highest risk for post procedure complications, such as falls due to the administration of anesthesia, which patient was noted to have spinal anesthesia.Pain medications such as narcotics and other forms of analgesia are normally given in recovery and continued during hospitalization to reduce and control patients post-operative pain.It can be presumed the patient had been given such medications.As anesthesia and pain medications can have multiple side effects causing confusion, dizziness, nausea, alteration in sensation which increases patients risk for a fall.Tka patients are at risk for falls due to the recent procedure itself, with the surgical procedure causing weakness, inability to stand or ambulate without assist or assistive device immediate post op.It was noted fall occurred during the night while in the hospital, patients have a known higher risk of falls at night due to disorientation from waking in unfamiliar place, as well as lighting can impact patients¿ ability to visualize pathway for ambulation.As the reported fall is procedural related event, which led to the adverse outcomes reported, it can be concluded that the fall is unrelated to the devices.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: ALL POLY PATELLA CEMENTED 29 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10705131
• Report Number: 0002648920-2020-00467
• Device Sequence Number: 3125268
• Product Code: JWH
• UDI-Device Identifier: 00889024247628
• UDI-Public: (01)00889024247628
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 42540000029
• Device Lot Number: 64775163
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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; Required Intervention
• Patient Weight: 96