MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE REGULAR CONSTRAINT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2019-00344, 0002648920-2019-00886.Concomitant medical products: femoral component option size e right item# 00595601502 lot# 64083412, stemmed nonaugmentable tibial component option cr/ps/lps item# 00598604702 lot# 64085499.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 one month post implantation due to infection, limited flexion, pain, and inflammation.The study patient was dismissed upon revision.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.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: inflammation, swelling, and pain medially.There were no signs of infection approximately five months¿ post implantation, with reports of inflammation and pain.Infection was confirmed approximately one year and one-week post implantation with swelling, pain, and osteolysis in the femur and tibia.The patient was revised due to staph epidermidis, with loss of bone due to osteolysis.Provided x-rays were reviewed and determined to not need further evaluation based on complaint of infection.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.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.
Event or Problem Description
It was reported that a patient was revised approximately one year and one month post implantation due to infection with staph epidermidis, limited flexion, pain, and inflammation.Loss of bone due to osteolysis was also noted.Infection was caused by previous surgery in the implant region less than one year ago.The study patient was dismissed upon revision.There is no additional information at this time.

• Brand Name: ARTICULAR SURFACE REGULAR CONSTRAINT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9445652
• Report Number: 0001822565-2019-05196
• Device Sequence Number: 13975637
• Product Code: JWH
• UDI-Device Identifier: 00889024263642
• UDI-Public: (01)00889024263642
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2020

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: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 90597004014
• Device Lot Number: 64015672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 01/22/2020; 02/17/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/11/2020; 02/20/2020
• 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 Age: 59 YR
• Patient Weight: 96