MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE F LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: item 00595204010, lot 64590069, item 110035368, lot 004cac2505, item 00597004502, lot 64645362.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains 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: (b)(4).

Event Description

It was reported that the patient underwent a left knee mua approximately two months post-implantation due to arthrofibrosis.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 limited range of motion and stiffness, complaint categories will be coded as medical: range of motion (rom): limited mobility and medical: stiffness.Additionally, the patient experienced surgical site wound complications in the immediate postoperative period which would likely have disrupted the expected progress with rehabilitation and range of motion exercises.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 Description

No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT PRECOAT SIZE F LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 11460131
• MDR Text Key: 239079954
• Report Number: 3007963827-2021-00053
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024207011
• UDI-Public: (01)00889024207011(17)300331(10)64586126
• Combination Product (y/n): N
• PMA/PMN Number: K023211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00595001601
• Device Lot Number: 64586126
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 96