MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D; PROSTHESIS, KNEE

Catalog Number	42532006701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown articular surface; femur cemented cruciate retaining (cr) narrow left size 7: catalog#42502006201, lot#65820941; optipac 60 refob bone cmt r-3: catalog#4711500396-3, lot#aw14da1311.G2: foreign: netherlands.G2: literature citation: eijking, h.M., hendrickx, r., van haaren, e.H., schotanus, m.G.M., dorling, i., bouwman, l., boonen, b., most, j.(2026).Robotic-assisted inverse kinematic aligned vs conventional mechanical aligned total knee arthroplasty.Unpublished manuscript.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
A manuscript was obtained on 06-jan-2026 that reported a randomized controlled trial study from the netherlands conducted from 05-dec-2022 and 03-jul-2024 at the zuyderland medical center.The purpose of the study was to compare robotic-assisted inverse kinematic alignment total knee arthroplasty with mechanically aligned total knee arthroplasty.A total of 150 patients were included and underwent randomization; 73 patients were assigned to the rosa robotic-assisted tka group and 77 patients to the conventional ma tka group.In the robotic-assisted tka group, 7 patients were converted to conventional tka.A standard medial parapatellar approach was used in all patients; patellar resurfacing was done only in selected cases and a fully cemented, cruciate retaining knee prosthesis was implanted.Zimmer biomet persona was used in all cases except vanguard in 2 cases.The study population had a mean age of 69.7 years at time of surgery; (51 males / 77 females).Follow-up consisted of functional and satisfaction scoring within 12 months with a minimum follow up of 12 months.The article reported one (1) patient in the conventional group experienced postoperative pain on an unknown timeframe before the twelve (12) month follow up.The patient required pain management plan remediation due to comorbidities.All available information today has been provided.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25166955
• Report Number: 3007963827-2026-00197
• Device Sequence Number: 10643694
• Product Code: MBH
• UDI-Device Identifier: 00889024471030
• UDI-Public: (01)00889024471030(17)330818(10)66098640
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: Lay User/Patient
• Device Catalogue Number: 42532006701
• Device Lot Number: 66098640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female