MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 35 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	Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: therapy date: unknown.42502006402 femur cemented cruciate retaining (cr) 63945498.42530007102 natural tibia tmt two-peg porous fixed bearing 62917428.42522100812 articular surface medial congruent 64119057.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: 3007963827-2020-00136.0001822565-2020-01648.3007963827-2020-00137.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, the patient reported continued difficulty with activity of daily living, ambulating, swelling, and stiffness over time.The patient remains dissatisfied but has received no further treatment/intervention.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Medical records/radiographs were evaluated and the reported event was not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following no intra-op complication noted.During the 1 year follow up visits, the patient experienced moderate pain, limping, difficulty with daily activities, stiffness, and swelling.No further action was taken.A definitive root cause cannot be determined.Per package insert, persona the personalized knee solution: swelling, pain, limited rom are known adverse effects of this procedure.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.

• Brand Name: ALL POLY PATELLA CEMENTED 35 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: 10032409
• Report Number: 0002648920-2020-00253
• Device Sequence Number: 14199752
• Product Code: JWH
• UDI-Device Identifier: 00889024247642
• UDI-Public: (01)00889024247642
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000035
• Device Lot Number: 64214480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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: Other
• Patient Age: 48 YR
• Patient Weight: 132