MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CR STANDARD RIGHT SIZE 8; PROSTHESIS, KNEE

Model Number	42-5026-064-02
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: articular surface fixed bearing cruciate retaining (cr) right 14 mm height: catalog#: 42521000514, lot#: 63455026; tibia cemented 5 degree stemmed right size e: catalog#: 42532007102, lot#: 63947833; all poly patella cemented 32 mm diameter: catalog#: 42540000032, lot#: 64129910; optipac-s 60 refob bn cmt r: catalog#: 4711500396-1, lot#: a746d06425.Foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2022-00595.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.The necessary intervention is a non-invasive technique performed for treating stiffness and poor range of motion following total joint replacement.There is no product involvement and performed due to scar tissue only.
Event or Problem Description
It was reported via a clinical study that a study patient underwent a primary total knee arthroplasty.Approximately three months post-implantation the patient underwent a closed brisement procedure due to a loss in range of motion.Attempts have been made and no further information has been provided.

• Brand Name: FEMUR CEMENTED CR STANDARD RIGHT SIZE 8
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13593883
• Report Number: 3007963827-2022-00057
• Device Sequence Number: 3860930
• Product Code: MBH
• UDI-Device Identifier: 00889024230385
• UDI-Public: (01)00889024230385(17)280630(10)63947833
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: 42-5026-064-02
• Device Catalogue Number: 42502606402
• Device Lot Number: 63947833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 88 KG