MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET STEM 11MMDX145MM; PROSTHESIS, KNEE

Catalog Number	00598802011
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: stem implant, #item 00598801013, #lot 62370149.Unk femoral component, #item unknown, #lot unknown.Unk tibial component, item #unknown, #lot unknown.Unk fixation screw, #item unknown, #lot unknown.Unk tibial spacer, #item unknown, #lot unknown.Unk femoral spacers, #item unknown, #lot unknown.Unk insert, #item unknown, #lot unknown.Therapy date: (b)(6) 2025.G2: foreign source country: italy.H6: component code: mechanical (g04) - stem.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported patient underwent a knee replacement revision approximately 19 years post implantation due to aseptic loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Follow up report.(b)(4).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 or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further information is 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,d2,d9,g1,g3,g6,h1,h2,h3,h6 the following sections were corrected:d1,d10 d10: stem, #item 00598801013, #lot 62370149 unk femoral component, #item unknown, #lot unknown unk tibial component, item #unknown, #lot unknown unk fixation screw, #item unknown, #lot unknown unk tibial augment, #item unknown, #lot unknown unk femoral augment, #item unknown, #lot unknown unk insert, #item unknown, #lot unknown therapy date: (b)(6) 2025 the cmp was confirmed offset stem pn 00598802011: visual examination of the returned product identified signs of use.Products were received assembled.Unable to verify taper or offset while assembled.Part visually matches the blueprint.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Stems: review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Insufficient information provided.Unable to perform a compatibility check.Offset stem pn 00598802011: review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: imaging findings - ap and lateral views of the right knee show postoperative changes of knee arthroplasty with constrained longstem femoral and tibial components (likely revision tka).The patella is thin and mild patella alta is noted.There is radiolucency around the distal aspect of the tibial stem with lateral positioning of the stem in the tibial diaphysis, suspicious for loosening.Marked osseous demineralization is noted.Impression - revision right knee arthroplasty with radiolucency around the tibial stem and varus alignment of the tibial component consistent with loosening.Of note, marked radiographic osteopenia is noted, which can predispose to implant loosening.A definitive root cause cannot be determined.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.

• Brand Name: OFFSET STEM 11MMDX145MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23865514
• Report Number: 0001822565-2025-04703
• Device Sequence Number: 19942937
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 00598802011
• Device Lot Number: 62409837
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 05/27/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/03/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown