MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 10; PROSTHESIS, KNEE

Model Number	42-5026-068-02
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface fixed bearing cruciate retaining (cr) right 10 mm height: catalog#42521000510, lot#63221004; tibia cemented 5 degree stemmed right size f: catalog#42532007502, lot#63821008.Report source: foreign: (b)(6).Multiple mdr reports were filed for this event, please see associated report: 0002648920-2021-00366.Customer has indicated that 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.
Event or Problem Description
It was reported via a (b)(6) clinical study that patient underwent an initial right total knee arthroplasty.Subsequently, patient reported increased stiffness and decreased range of motion for a six month period, beginning 1.5 years post implantation.Patient was advised to begin physiotherapy to increase knee flexion.Products remain implanted.Final outcome is pending at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history records were reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for these items and the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: increased stiffness and decreased rom for 6 months at 2 year follow up; post-op x-ray showed no loosening, or periprosthetic fracture; 2 year follow up x-ray showed no loosening, or periprosthetic fracture; significant reduction of mobility due to shielding of covid-19, no current need for revision, recommended post op exercises at least 3 times a day, will reassess.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported via a polar-tka clinical study that the patient underwent an initial right total knee arthroplasty.Subsequently, the patient reported increased stiffness and decreased range of motion for a six month period, beginning 1.5 years post implantation.Patient was advised to begin physiotherapy to increase knee flexion.Surgeon noted that patient's mobility has decreased due to the covid-19 pandemic and feels that the decreased activity has caused deterioration in joint function.At the time of this report, products remain implanted and there is no plan for revision surgery.Final outcome is noted as pending.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 10
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 12689839
• Report Number: 3007963827-2021-00253
• Device Sequence Number: 14479058
• Product Code: MBH
• UDI-Device Identifier: 00889024230422
• UDI-Public: (01)00889024230422(17)280229(10)63937423
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 42-5026-068-02
• Device Catalogue Number: 42502606802
• Device Lot Number: 63937423
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 116