MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 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	Loss of Range of Motion (2032); Scar Tissue (2060); Limited Mobility Of The Implanted Joint (2671)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00185 and 3007963827-2020-00186.Medical devices: femur cemented cruciate retaining (cr) standard left size 8 catalog#: 42502606401 lot#: 64439138, articular surface medial congruent (mc) left 12 mm height catalog#: 42512100812 lot#: 64419807, natural tibia cemented 5 degree stemmed left size e catalog#: 42532007101 lot#: 64459817.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 patient underwent left knee manipulation under anesthesia approximately two months after initial implantation due to stiffness, difficulty ambulating, limited range of motion, and a diagnosis of arthrofibrosis.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.Updated: b4, g4, g7, h2, h3, h6, and h10.Arthrofibrosis is defined as a complication of injury or trauma where an excessive scar tissue response leads to painful restriction of joint motion, with scar tissue forming within the joint and surrounding soft tissue spaces and persisting despite rehabilitation exercises and stretches.A manipulation of the joint is needed to loosen the scar tissue to regain range of motion.Manipulation under anesthesia is a non-invasive technique performed for treating stiffness and poor range of motion following total joint replacement.According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Per clinical orthropaedics and related research (how to treat the stiff total knee arthroplasty?: a systematic review), mua is used to treat and resolve arthrofibrosis (scar tissue).This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.As the indication for manipulation under anesthesia is related to arthrofibrosis, limited range of motion and stiffness, complaint categories will be coded as medical : adhesions/scar tissue, medical: range of motion (rom): limited mobility and medical: stiffness.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ALL POLY PATELLA CEMENTED 38 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: 10356062
• Report Number: 0002648920-2020-00362
• Device Sequence Number: 2330307
• Product Code: JWH
• UDI-Device Identifier: 00889024247659
• UDI-Public: (01)00889024247659(17)271031(10)64580484
• Combination Product (Y/N): N
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000038
• Device Lot Number: 64580484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/07/2020; 09/25/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/31/2020; 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 79