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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism (1829); Pain (1994); Swelling (2091)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00213, 3007963827-2020-00214, 3007963827-2020-00215.Medical devices: femur cemented posterior stabilized (ps) narrow right size 8 catalog#: 42500006402 lot#: 64441570, tibia cemented 5 degree stemmed right size d catalog#: 42532006702 lot#: 64318875, articular surface fixed bearing (ps) right 11 mm height catalog#: 42522400511 lot#: 64405629.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 the patient had a deep vein thrombosis approximately a week after right knee arthroplasty.No additional patient consequences were reported.
Event or Problem Description
It was reported that the patient had a deep vein thrombosis approximately one week after right knee arthroplasty.The patient was prescribed an anticoagulant and remained on it for approximately 3 months with no further mention of deep vein thrombosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, b7, g4, g7, h2, h3, h6, and h10.Procedural related complications are influenced by the "type of surgery, patients pre-existing comorbid state, and perioperative management." deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot.Even with the administration of preventive medication, dvt/blood clots can still develop.As the complaint indicated a post-operative complication of dvt developed and it can be implied medical intervention was required to treat the complication, therefore our complaint category, medical: procedure related would be appropriate.

• 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: 10482363
• Report Number: 0002648920-2020-00394
• Device Sequence Number: 17175967
• Product Code: JWH
• UDI-Device Identifier: 00889024247628
• UDI-Public: (01)00889024247628
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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 Model Number: N/A
• Device Catalogue Number: 42540000029
• Device Lot Number: 64620917
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: Other
• Patient Weight: 64